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SPYRAL HTN-ON MED Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439775
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Results First Posted : September 15, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Hypertension
Vascular Diseases
Cardiovascular Diseases
Interventions Device: Symplicity Spyral™ multi-electrode renal denervation system
Procedure: Sham Procedure
Enrollment 337
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Period Title: Overall Study
Started 206 131
Completed 115 73
Not Completed 91 58
Arm/Group Title Renal Denervation Sham Procedure Total
Hide Arm/Group Description

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Total of all reporting groups
Overall Number of Baseline Participants 206 131 337
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 131 participants 337 participants
55.2  (9.0) 54.6  (9.4) 54.9  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 131 participants 337 participants
Female
39
  18.9%
28
  21.4%
67
  19.9%
Male
167
  81.1%
103
  78.6%
270
  80.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 131 participants 337 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
17
   8.3%
10
   7.6%
27
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
35
  17.0%
25
  19.1%
60
  17.8%
White
71
  34.5%
48
  36.6%
119
  35.3%
More than one race
2
   1.0%
0
   0.0%
2
   0.6%
Unknown or Not Reported
81
  39.3%
48
  36.6%
129
  38.3%
Length of hypertension diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 131 participants 337 participants
0-5 years
62
  30.1%
24
  18.3%
86
  25.5%
6-10 years
37
  18.0%
27
  20.6%
64
  19.0%
>10 years
107
  51.9%
80
  61.1%
187
  55.5%
Office Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 206 participants 131 participants 337 participants
Office Systolic Blood Pressure 163.0  (7.7) 163.1  (7.9) 163.05  (7.8)
Office Diastolic Blood Pressure 101.2  (7.0) 101.5  (7.3) 101.4  (7.2)
24- hour Ambulatory Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 206 participants 131 participants 337 participants
24- hour Ambulatory Systolic Blood Pressure 149.6  (7.0) 149.3  (7.0) 149.5  (7.0)
24-hour Ambulatory Diastolic Blood Pressure 96.6  (7.6) 95.7  (7.7) 96.2  (7.65)
1.Primary Outcome
Title Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Hide Description The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: All-cause mortality, End Stage Renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis >70%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
Time Frame From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects are analyzed according to their randomized treatment.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 206 131
Measure Type: Count of Participants
Unit of Measure: Participants
No MAE
204
  99.0%
130
  99.2%
Vascular Complication requiring intervention
2
   1.0%
1
   0.8%
2.Primary Outcome
Title Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Hide Description Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Time Frame From baseline to 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects are analyzed according to their randomized treatment. Subjects who met the anti-hypertensive medication escape criteria (Office SBP>180 or <115 mmHg associated with symptoms of hypotension or safety concern requiring medication changes) are analyzed using Last Observation Carried Forward (LOCF) for their blood pressure measurements out to 6-months.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 192 116
Mean (Standard Deviation)
Unit of Measure: mm Hg
-6.5  (10.7) -4.5  (10.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Renal Denervation, Sham Procedure
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1194
Comments p<0.05 required for significance
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Office Systolic Blood Pressure
Hide Description Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
Time Frame From baseline to 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Valid readings at time of data collection
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 199 126
Mean (Standard Deviation)
Unit of Measure: mmHg
-9.9  (13.9) -5.1  (13.2)
4.Secondary Outcome
Title Antihypertensive Medication Usage and Changes to 6-months
Hide Description Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure
Time Frame From baseline to 6-month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Prescribed daily medication reported
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 206 131
Mean (Standard Deviation)
Unit of Measure: Number of Daily Medications
Baseline Number Analyzed 206 participants 131 participants
1.9  (.8) 1.9  (0.8)
6 Months Number Analyzed 204 participants 130 participants
1.9  (0.9) 2.1  (0.9)
5.Secondary Outcome
Title Antihypertensive Medication Burden to 6-months
Hide Description

Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.

Minimum value 0; No Maximum value

Time Frame From baseline to 6 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Prescribed medications reported
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 206 131
Mean (Standard Deviation)
Unit of Measure: Medication Index 2 Score
Baseline Number Analyzed 206 participants 131 participants
2.8  (2.5) 3.0  (2.6)
6 Months Number Analyzed 204 participants 130 participants
2.9  (2.7) 3.5  (3.2)
6.Secondary Outcome
Title Medication Changes
Hide Description Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency.
Time Frame Baseline to 6-months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Confirmed via Drug Testing Data at both Baseline (Screening Visit 2) and 6-months post-procedure
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 200 128
Measure Type: Count of Participants
Unit of Measure: Participants
Increase
37
  18.5%
35
  27.3%
No Change
131
  65.5%
80
  62.5%
Decrease
32
  16.0%
13
  10.2%
7.Secondary Outcome
Title Incidence of Achieving Target Office Systolic Blood Pressure
Hide Description Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.
Time Frame From baseline to 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Valid readings at time of data collection
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Overall Number of Participants Analyzed 199 126
Measure Type: Count of Participants
Unit of Measure: Participants
39
  19.6%
8
   6.3%
Time Frame Adverse Events through 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Renal angiography

Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

All-Cause Mortality
Renal Denervation Sham Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/206 (0.00%)   0/131 (0.00%) 
Hide Serious Adverse Events
Renal Denervation Sham Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   18/206 (8.74%)   15/131 (11.45%) 
Cardiac disorders     
Atrial Fibrillation  1  1/206 (0.49%)  0/131 (0.00%) 
Atrial Flutter  1  1/206 (0.49%)  0/131 (0.00%) 
Bradycardia  1  1/206 (0.49%)  1/131 (0.76%) 
Cardiac Failure Congestive  1  0/206 (0.00%)  1/131 (0.76%) 
Angina Unstable  1  0/206 (0.00%)  0/131 (0.00%) 
Endocrine disorders     
Adrenal Mass  1  1/206 (0.49%)  0/131 (0.00%) 
Eye disorders     
Retinal Detachment  1  0/206 (0.00%)  0/131 (0.00%) 
Gastrointestinal disorders     
Colitis Ulcerative  1  0/206 (0.00%)  1/131 (0.76%) 
Gastrooesophageal Reflux Disease  1  0/206 (0.00%)  0/131 (0.00%) 
General disorders     
Asthenia  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Chest Discomfort  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Non-Cardiac Chest Pain  1 [1]  1/206 (0.49%)  1/131 (0.76%) 
Oedema Peripheral  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Chest Pain  1  0/206 (0.00%)  0/131 (0.00%) 
Hepatobiliary disorders     
Bile Duct Stone  1  1/206 (0.49%)  0/131 (0.00%) 
Cholecystitis Acute  1  0/206 (0.00%)  1/131 (0.76%) 
Infections and infestations     
Pneumonia  1  1/206 (0.49%)  1/131 (0.76%) 
Vestibular Neuronitis  1  1/206 (0.49%)  0/131 (0.00%) 
Viral Sepsis  1  1/206 (0.49%)  0/131 (0.00%) 
Diverticulitis  1  0/206 (0.00%)  0/131 (0.00%) 
Injury, poisoning and procedural complications     
Meniscus Injury  1  1/206 (0.49%)  0/131 (0.00%) 
Upper Limb Fracture  1  1/206 (0.49%)  0/131 (0.00%) 
Vascular Access Site Haematoma  1  1/206 (0.49%)  0/131 (0.00%) 
Vascular Access Site Pseudoaneurysm  1  2/206 (0.97%)  1/131 (0.76%) 
Metabolism and nutrition disorders     
Diabetes Mellitus  1  1/206 (0.49%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/206 (0.49%)  1/131 (0.76%) 
Back Pain  1  1/206 (0.49%)  1/131 (0.76%) 
Cervical Spinal Stenosis  1  0/206 (0.00%)  1/131 (0.76%) 
Intervertebral Disc Protrusion  1  0/206 (0.00%)  1/131 (0.76%) 
Osteoarthritis  1  1/206 (0.49%)  1/131 (0.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital Warts  1  0/206 (0.00%)  1/131 (0.76%) 
Lung Adenocarcinoma  1  0/206 (0.00%)  1/131 (0.76%) 
Metastases To Lung  1  1/206 (0.49%)  0/131 (0.00%) 
Prostate Cancer  1  0/206 (0.00%)  1/131 (0.76%) 
Renal Cell Carcinoma  1  1/206 (0.49%)  0/131 (0.00%) 
Bladder Neoplasm  1  0/206 (0.00%)  0/131 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident  1  0/206 (0.00%)  1/131 (0.76%) 
Headache  1  0/206 (0.00%)  1/131 (0.76%) 
Simple Partial Seizures  1  0/206 (0.00%)  0/131 (0.00%) 
Subarachnoid Haemorrhage  1  0/206 (0.00%)  0/131 (0.00%) 
Syncope  1  0/206 (0.00%)  0/131 (0.00%) 
Psychiatric disorders     
Nervousness  1  0/206 (0.00%)  0/131 (0.00%) 
Renal and urinary disorders     
Bladder Neck Obstruction  1  0/206 (0.00%)  1/131 (0.76%) 
Renal Artery Stenosis  1  0/206 (0.00%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea Exertional  1  0/206 (0.00%)  0/131 (0.00%) 
Surgical and medical procedures     
Removal Of Foreign Body  1  1/206 (0.49%)  0/131 (0.00%) 
Vascular disorders     
Raynaud's Phenomenon  1  1/206 (0.49%)  0/131 (0.00%) 
Hypertensive Crisis  1  0/206 (0.00%)  0/131 (0.00%) 
1
Term from vocabulary, MedDRA (25.0)
Indicates events were collected by systematic assessment
[1]
General Disorders And Administration Site Conditions
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Renal Denervation Sham Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   129/206 (62.62%)   89/131 (67.94%) 
Blood and lymphatic system disorders     
Anemia  1  1/206 (0.49%)  1/131 (0.76%) 
Iron Deficiency Anaemia  1  0/206 (0.00%)  1/131 (0.76%) 
Leukocytosis  1  0/206 (0.00%)  1/131 (0.76%) 
Cardiac disorders     
Angina Pectoris  1  0/206 (0.00%)  1/131 (0.76%) 
Atrial Fibrillation  1  2/206 (0.97%)  2/131 (1.53%) 
Atrial Flutter  1  1/206 (0.49%)  0/131 (0.00%) 
Atrioventricular Block Second Degree  1  0/206 (0.00%)  1/131 (0.76%) 
Bradycardia  1  3/206 (1.46%)  1/131 (0.76%) 
Cardiac Failure Congestive  1  0/206 (0.00%)  1/131 (0.76%) 
Left Ventricular Failure  1  0/206 (0.00%)  1/131 (0.76%) 
Palpitations  1  0/206 (0.00%)  1/131 (0.76%) 
Sinus Tachycardia  1  1/206 (0.49%)  0/131 (0.00%) 
Tachycardia  1  2/206 (0.97%)  1/131 (0.76%) 
Angina Unstable  1  0/206 (0.00%)  0/131 (0.00%) 
Cardiac Hypertrophy  1  0/206 (0.00%)  0/131 (0.00%) 
Congenital, familial and genetic disorders     
Liddle's Syndrome  1  0/206 (0.00%)  0/131 (0.00%) 
Ear and labyrinth disorders     
Ear Pain  1  0/206 (0.00%)  1/131 (0.76%) 
Tinnitus  1  1/206 (0.49%)  0/131 (0.00%) 
Endocrine disorders     
Adrenal Mass  1  1/206 (0.49%)  0/131 (0.00%) 
Basedow's Disease  1  0/206 (0.00%)  1/131 (0.76%) 
Hypothyroidism  1  0/206 (0.00%)  2/131 (1.53%) 
Primary Hyperaldosteronism  1  1/206 (0.49%)  0/131 (0.00%) 
Eye disorders     
Conjunctivitis Allergic  1  1/206 (0.49%)  0/131 (0.00%) 
Swelling Of Eyelid  1  0/206 (0.00%)  1/131 (0.76%) 
Vision Blurred  1  0/206 (0.00%)  1/131 (0.76%) 
Visual Impairment  1  1/206 (0.49%)  0/131 (0.00%) 
Retinal Detachment  1  0/206 (0.00%)  0/131 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort  1  3/206 (1.46%)  1/131 (0.76%) 
Colitis  1  1/206 (0.49%)  0/131 (0.00%) 
Colitis Ulcerative  1  1/206 (0.49%)  1/131 (0.76%) 
Constipation  1  1/206 (0.49%)  1/131 (0.76%) 
Diarrhoea  1  2/206 (0.97%)  2/131 (1.53%) 
Dyspepsia  1  1/206 (0.49%)  0/131 (0.00%) 
Food Poisoning  1  1/206 (0.49%)  0/131 (0.00%) 
Gastritis  1  2/206 (0.97%)  0/131 (0.00%) 
Gastrooesophageal Reflux Disease  1  1/206 (0.49%)  0/131 (0.00%) 
Haemorrhoids  1  0/206 (0.00%)  1/131 (0.76%) 
Inguinal Hernia  1  1/206 (0.49%)  0/131 (0.00%) 
Lip Swelling  1  0/206 (0.00%)  1/131 (0.76%) 
Nausea  1  3/206 (1.46%)  0/131 (0.00%) 
Toothache  1  2/206 (0.97%)  2/131 (1.53%) 
Abdominal Pain Upper  1  0/206 (0.00%)  0/131 (0.00%) 
Diverticulum  1  0/206 (0.00%)  0/131 (0.00%) 
Paraesthesia Oral  1  0/206 (0.00%)  0/131 (0.00%) 
Stomach Mass  1  0/206 (0.00%)  0/131 (0.00%) 
Vomiting  1  0/206 (0.00%)  0/131 (0.00%) 
General disorders     
Adverse Drug Reaction  1 [1]  1/206 (0.49%)  1/131 (0.76%) 
Asthenia  1 [1]  1/206 (0.49%)  1/131 (0.76%) 
Chest Discomfort  1 [1]  1/206 (0.49%)  1/131 (0.76%) 
Chest Pain  1 [1]  1/206 (0.49%)  4/131 (3.05%) 
Cyst  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Drug Intolerance  1 [1]  1/206 (0.49%)  0/131 (0.00%) 
Fat Necrosis  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Fatigue  1 [1]  2/206 (0.97%)  1/131 (0.76%) 
Influenza Like Illness  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Non-Cardiac Chest Pain  1 [1]  1/206 (0.49%)  1/131 (0.76%) 
Oedema Peripheral  1 [1]  6/206 (2.91%)  12/131 (9.16%) 
Peripheral Swelling  1 [1]  3/206 (1.46%)  2/131 (1.53%) 
Puncture Site Haematoma  1 [1]  1/206 (0.49%)  0/131 (0.00%) 
Pyrexia  1 [1]  1/206 (0.49%)  0/131 (0.00%) 
Swelling  1 [1]  0/206 (0.00%)  1/131 (0.76%) 
Vessel Puncture Site Haematoma  1 [1]  1/206 (0.49%)  0/131 (0.00%) 
Vessel Puncture Site Induration  1 [1]  1/206 (0.49%)  0/131 (0.00%) 
Pain  1 [1]  0/206 (0.00%)  0/131 (0.00%) 
Hepatobiliary disorders     
Bile Duct Stone  1  1/206 (0.49%)  0/131 (0.00%) 
Cholecystitis Acute  1  0/206 (0.00%)  1/131 (0.76%) 
Cholelithiasis  1  0/206 (0.00%)  1/131 (0.76%) 
Hepatic Lesion  1  1/206 (0.49%)  0/131 (0.00%) 
Hepatic Steatosis  1  0/206 (0.00%)  1/131 (0.76%) 
Immune system disorders     
Contrast Media Reaction  1  1/206 (0.49%)  0/131 (0.00%) 
Hypersensitivity  1  0/206 (0.00%)  1/131 (0.76%) 
Infections and infestations     
Bacterial Vaginosis  1  1/206 (0.49%)  0/131 (0.00%) 
Bronchitis  1  3/206 (1.46%)  0/131 (0.00%) 
Bursitis Infective  1  1/206 (0.49%)  0/131 (0.00%) 
Cellulitis  1  2/206 (0.97%)  1/131 (0.76%) 
Conjunctivitis  1  1/206 (0.49%)  0/131 (0.00%) 
Conjunctivitis Viral  1  1/206 (0.49%)  0/131 (0.00%) 
Covid-19  1  5/206 (2.43%)  3/131 (2.29%) 
Cystitis  1  1/206 (0.49%)  1/131 (0.76%) 
Eye Infection  1  1/206 (0.49%)  0/131 (0.00%) 
Folliculitis  1  1/206 (0.49%)  0/131 (0.00%) 
Fungal Foot Infection  1  1/206 (0.49%)  0/131 (0.00%) 
Gastroenteritis  1  0/206 (0.00%)  1/131 (0.76%) 
Gastrointestinal Viral Infection  1  0/206 (0.00%)  1/131 (0.76%) 
Groin Abscess  1  1/206 (0.49%)  0/131 (0.00%) 
Infectious Mononucleosis  1  1/206 (0.49%)  0/131 (0.00%) 
Influenza  1  2/206 (0.97%)  6/131 (4.58%) 
Localised Infection  1  1/206 (0.49%)  0/131 (0.00%) 
Lower Respiratory Tract Infection  1  0/206 (0.00%)  1/131 (0.76%) 
Ludwig Angina  1  1/206 (0.49%)  0/131 (0.00%) 
Nasopharyngitis  1  3/206 (1.46%)  2/131 (1.53%) 
Onychomycosis  1  0/206 (0.00%)  1/131 (0.76%) 
Oral Herpes  1  1/206 (0.49%)  0/131 (0.00%) 
Paronychia  1  1/206 (0.49%)  0/131 (0.00%) 
Pneumonia  1  2/206 (0.97%)  1/131 (0.76%) 
Pulpitis Dental  1  1/206 (0.49%)  0/131 (0.00%) 
Respiratory Tract Infection  1  1/206 (0.49%)  1/131 (0.76%) 
Rhinitis  1  0/206 (0.00%)  1/131 (0.76%) 
Scrotal Abscess  1  1/206 (0.49%)  0/131 (0.00%) 
Sinusitis  1  1/206 (0.49%)  1/131 (0.76%) 
Tinea Cruris  1  0/206 (0.00%)  1/131 (0.76%) 
Tinea Pedis  1  0/206 (0.00%)  1/131 (0.76%) 
Tonsillitis  1  1/206 (0.49%)  1/131 (0.76%) 
Tooth Abscess  1  1/206 (0.49%)  0/131 (0.00%) 
Tooth Infection  1  1/206 (0.49%)  0/131 (0.00%) 
Upper Respiratory Tract Infection  1  1/206 (0.49%)  3/131 (2.29%) 
Urethritis  1  0/206 (0.00%)  1/131 (0.76%) 
Urinary Tract Infection  1  0/206 (0.00%)  2/131 (1.53%) 
Vestibular Neuronitis  1  1/206 (0.49%)  0/131 (0.00%) 
Viral Sepsis  1  1/206 (0.49%)  0/131 (0.00%) 
Viral Upper Respiratory Tract Infection  1  1/206 (0.49%)  1/131 (0.76%) 
Wound Infection Staphylococcal  1  1/206 (0.49%)  0/131 (0.00%) 
Acute Sinusitis  1  0/206 (0.00%)  0/131 (0.00%) 
Diverticulitis  1  0/206 (0.00%)  0/131 (0.00%) 
Ear Infection  1  0/206 (0.00%)  0/131 (0.00%) 
Gastrointestinal Infection  1  0/206 (0.00%)  0/131 (0.00%) 
Pyelonephritis  1  0/206 (0.00%)  0/131 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod Bite  1  1/206 (0.49%)  0/131 (0.00%) 
Contusion  1  0/206 (0.00%)  2/131 (1.53%) 
Exposure To Extreme Temperature  1  1/206 (0.49%)  0/131 (0.00%) 
Fall  1  1/206 (0.49%)  0/131 (0.00%) 
Foot Fracture  1  0/206 (0.00%)  1/131 (0.76%) 
Head Injury  1  1/206 (0.49%)  0/131 (0.00%) 
Incision Site Complication  1  1/206 (0.49%)  0/131 (0.00%) 
Incision Site Pain  1  0/206 (0.00%)  1/131 (0.76%) 
Ligament Sprain  1  1/206 (0.49%)  0/131 (0.00%) 
Lower Limb Fracture  1  1/206 (0.49%)  0/131 (0.00%) 
Meniscus Injury  1  1/206 (0.49%)  0/131 (0.00%) 
Muscle Strain  1  0/206 (0.00%)  1/131 (0.76%) 
Post Procedural Discomfort  1  0/206 (0.00%)  1/131 (0.76%) 
Procedural Pain  1  1/206 (0.49%)  1/131 (0.76%) 
Skin Abrasion  1  1/206 (0.49%)  0/131 (0.00%) 
Skin Laceration  1  2/206 (0.97%)  0/131 (0.00%) 
Soft Tissue Injury  1  1/206 (0.49%)  0/131 (0.00%) 
Stoma Prolapse  1  1/206 (0.49%)  0/131 (0.00%) 
Thermal Burn  1  0/206 (0.00%)  1/131 (0.76%) 
Tooth Fracture  1  1/206 (0.49%)  0/131 (0.00%) 
Upper Limb Fracture  1  1/206 (0.49%)  0/131 (0.00%) 
Vaccination Complication  1  1/206 (0.49%)  0/131 (0.00%) 
Vascular Access Site Bruising  1  2/206 (0.97%)  0/131 (0.00%) 
Vascular Access Site Haematoma  1  10/206 (4.85%)  10/131 (7.63%) 
Vascular Access Site Haemorrhage  1  2/206 (0.97%)  1/131 (0.76%) 
Vascular Access Site Pain  1  5/206 (2.43%)  0/131 (0.00%) 
Vascular Access Site Pseudoaneurysm  1  2/206 (0.97%)  1/131 (0.76%) 
Vascular Access Site Thrombosis  1  1/206 (0.49%)  0/131 (0.00%) 
Wound Secretion  1  1/206 (0.49%)  0/131 (0.00%) 
Bone Contusion  1  0/206 (0.00%)  0/131 (0.00%) 
Scratch  1  0/206 (0.00%)  0/131 (0.00%) 
Subcutaneous Haematoma  1  0/206 (0.00%)  0/131 (0.00%) 
Investigations     
Blood Cholesterol Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Blood Creatinine Increased  1  1/206 (0.49%)  3/131 (2.29%) 
Blood Glucose Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Blood Potassium Decreased  1  2/206 (0.97%)  0/131 (0.00%) 
Blood Potassium Increased  1  0/206 (0.00%)  1/131 (0.76%) 
Blood Pressure Abnormal  1  1/206 (0.49%)  0/131 (0.00%) 
Blood Pressure Increased  1  6/206 (2.91%)  4/131 (3.05%) 
Blood Pressure Orthostatic Decreased  1  0/206 (0.00%)  1/131 (0.76%) 
Blood Uric Acid Increased  1  1/206 (0.49%)  0/131 (0.00%) 
C-Reactive Protein Increased  1  0/206 (0.00%)  1/131 (0.76%) 
Gamma-Glutamyltransferase Increased  1  0/206 (0.00%)  1/131 (0.76%) 
Glycosylated Haemoglobin Increased  1  1/206 (0.49%)  1/131 (0.76%) 
Heart Rate Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Hepatic Enzyme Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Lipids Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Liver Function Test Increased  1  1/206 (0.49%)  1/131 (0.76%) 
Oxygen Saturation Decreased  1  1/206 (0.49%)  0/131 (0.00%) 
Pancreatic Enzymes Increased  1  1/206 (0.49%)  0/131 (0.00%) 
Renal Function Test Abnormal  1  1/206 (0.49%)  0/131 (0.00%) 
Troponin T Increased  1  0/206 (0.00%)  1/131 (0.76%) 
Weight Increased  1  0/206 (0.00%)  1/131 (0.76%) 
Aortic Bruit  1  0/206 (0.00%)  0/131 (0.00%) 
Liver Function Test Abnormal  1  0/206 (0.00%)  0/131 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  1/206 (0.49%)  0/131 (0.00%) 
Diabetes Mellitus  1  1/206 (0.49%)  1/131 (0.76%) 
Dyslipidaemia  1  1/206 (0.49%)  1/131 (0.76%) 
Gout  1  2/206 (0.97%)  0/131 (0.00%) 
Hypercholesterolaemia  1  3/206 (1.46%)  2/131 (1.53%) 
Hyperglycaemia  1  1/206 (0.49%)  1/131 (0.76%) 
Hyperkalaemia  1  2/206 (0.97%)  1/131 (0.76%) 
Hyperlipidaemia  1  2/206 (0.97%)  1/131 (0.76%) 
Hypokalaemia  1  12/206 (5.83%)  8/131 (6.11%) 
Hypolipidaemia  1  1/206 (0.49%)  0/131 (0.00%) 
Hypomagnesaemia  1  1/206 (0.49%)  0/131 (0.00%) 
Hyponatraemia  1  1/206 (0.49%)  0/131 (0.00%) 
Type 2 Diabetes Mellitus  1  2/206 (0.97%)  0/131 (0.00%) 
Dehydration  1  0/206 (0.00%)  0/131 (0.00%) 
Diabetes Mellitus Inadequate Control  1  0/206 (0.00%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/206 (1.94%)  4/131 (3.05%) 
Back Pain  1  12/206 (5.83%)  4/131 (3.05%) 
Bone Pain  1  1/206 (0.49%)  0/131 (0.00%) 
Bursitis  1  0/206 (0.00%)  1/131 (0.76%) 
Cervical Spinal Stenosis  1  0/206 (0.00%)  1/131 (0.76%) 
Facet Joint Syndrome  1  0/206 (0.00%)  1/131 (0.76%) 
Flank Pain  1  1/206 (0.49%)  0/131 (0.00%) 
Groin Pain  1  1/206 (0.49%)  0/131 (0.00%) 
Inguinal Mass  1  1/206 (0.49%)  0/131 (0.00%) 
Intervertebral Disc Protrusion  1  0/206 (0.00%)  1/131 (0.76%) 
Joint Effusion  1  1/206 (0.49%)  0/131 (0.00%) 
Joint Swelling  1  0/206 (0.00%)  1/131 (0.76%) 
Muscle Spasms  1  2/206 (0.97%)  2/131 (1.53%) 
Musculoskeletal Chest Pain  1  1/206 (0.49%)  0/131 (0.00%) 
Musculoskeletal Discomfort  1  4/206 (1.94%)  2/131 (1.53%) 
Musculoskeletal Pain  1  0/206 (0.00%)  1/131 (0.76%) 
Osteoarthritis  1  3/206 (1.46%)  1/131 (0.76%) 
Pain In Extremity  1  3/206 (1.46%)  5/131 (3.82%) 
Plantar Fasciitis  1  0/206 (0.00%)  1/131 (0.76%) 
Rotator Cuff Syndrome  1  1/206 (0.49%)  0/131 (0.00%) 
Tenosynovitis  1  1/206 (0.49%)  1/131 (0.76%) 
Arthritis  1  0/206 (0.00%)  0/131 (0.00%) 
Pain In Jaw  1  0/206 (0.00%)  0/131 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Adenocarcinoma  1  0/206 (0.00%)  1/131 (0.76%) 
Metastases To Lung  1  1/206 (0.49%)  0/131 (0.00%) 
Prostate Cancer  1  0/206 (0.00%)  1/131 (0.76%) 
Renal Cell Carcinoma  1  1/206 (0.49%)  0/131 (0.00%) 
Anogenital Warts  1  0/206 (0.00%)  1/131 (0.76%) 
Bladder Neoplasm  1  0/206 (0.00%)  0/131 (0.00%) 
Nervous system disorders     
Carpal Tunnel Syndrome  1  1/206 (0.49%)  0/131 (0.00%) 
Cerebrovascular Accident  1  0/206 (0.00%)  1/131 (0.76%) 
Dizziness  1  5/206 (2.43%)  6/131 (4.58%) 
Dizziness Postural  1  0/206 (0.00%)  1/131 (0.76%) 
Headache  1  7/206 (3.40%)  9/131 (6.87%) 
Hypoaesthesia  1  0/206 (0.00%)  2/131 (1.53%) 
Ischaemic Stroke  1  0/206 (0.00%)  1/131 (0.76%) 
Lethargy  1  0/206 (0.00%)  1/131 (0.76%) 
Leukoencephalopathy  1  0/206 (0.00%)  1/131 (0.76%) 
Migraine  1  0/206 (0.00%)  2/131 (1.53%) 
Nerve Compression  1  1/206 (0.49%)  0/131 (0.00%) 
Neuropathy Peripheral  1  0/206 (0.00%)  1/131 (0.76%) 
Paraesthesia  1  1/206 (0.49%)  1/131 (0.76%) 
Presyncope  1  3/206 (1.46%)  1/131 (0.76%) 
Radiculopathy  1  0/206 (0.00%)  1/131 (0.76%) 
Sciatic Nerve Neuropathy  1  1/206 (0.49%)  0/131 (0.00%) 
Syncope  1  1/206 (0.49%)  2/131 (1.53%) 
Bell's Palsy  1  0/206 (0.00%)  0/131 (0.00%) 
Cognitive Disorder  1  0/206 (0.00%)  0/131 (0.00%) 
Exertional Headache  1  0/206 (0.00%)  0/131 (0.00%) 
Sciatica  1  0/206 (0.00%)  0/131 (0.00%) 
Simple Partial Seizures  1  0/206 (0.00%)  0/131 (0.00%) 
Subarachnoid Haemorrhage  1  0/206 (0.00%)  0/131 (0.00%) 
Psychiatric disorders     
Anxiety  1  2/206 (0.97%)  0/131 (0.00%) 
Depression  1  1/206 (0.49%)  0/131 (0.00%) 
Mental Disorder  1  1/206 (0.49%)  0/131 (0.00%) 
Mental Status Changes  1  0/206 (0.00%)  1/131 (0.76%) 
Neuropsychiatric Symptoms  1  0/206 (0.00%)  1/131 (0.76%) 
Poor Quality Sleep  1  1/206 (0.49%)  0/131 (0.00%) 
Nervousness  1  0/206 (0.00%)  0/131 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury  1  1/206 (0.49%)  0/131 (0.00%) 
Bladder Neck Obstruction  1  0/206 (0.00%)  1/131 (0.76%) 
Hydronephrosis  1  0/206 (0.00%)  1/131 (0.76%) 
Hypertonic Bladder  1  0/206 (0.00%)  1/131 (0.76%) 
Micturition Urgency  1  0/206 (0.00%)  1/131 (0.76%) 
Renal Artery Dissection  1  2/206 (0.97%)  0/131 (0.00%) 
Renal Cyst  1  3/206 (1.46%)  0/131 (0.00%) 
Urinary Incontinence  1  0/206 (0.00%)  1/131 (0.76%) 
Urinary Retention  1  0/206 (0.00%)  1/131 (0.76%) 
Cystitis Noninfective  1  0/206 (0.00%)  0/131 (0.00%) 
Renal Artery Stenosis  1  0/206 (0.00%)  0/131 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/206 (0.49%)  1/131 (0.76%) 
Breast Mass  1  1/206 (0.49%)  0/131 (0.00%) 
Dysmenorrhoea  1  0/206 (0.00%)  1/131 (0.76%) 
Erectile Dysfunction  1  0/206 (0.00%)  1/131 (0.76%) 
Prostatitis  1  0/206 (0.00%)  1/131 (0.76%) 
Scrotal Cyst  1  0/206 (0.00%)  1/131 (0.76%) 
Testicular Pain  1  1/206 (0.49%)  1/131 (0.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/206 (2.91%)  1/131 (0.76%) 
Cough Variant Asthma  1  1/206 (0.49%)  0/131 (0.00%) 
Dyspnoea  1  0/206 (0.00%)  1/131 (0.76%) 
Dyspnoea Exertional  1  0/206 (0.00%)  1/131 (0.76%) 
Epistaxis  1  1/206 (0.49%)  1/131 (0.76%) 
Hypoxia  1  1/206 (0.49%)  0/131 (0.00%) 
Oropharyngeal Pain  1  3/206 (1.46%)  0/131 (0.00%) 
Respiratory Depression  1  1/206 (0.49%)  0/131 (0.00%) 
Sleep Apnoea Syndrome  1  1/206 (0.49%)  0/131 (0.00%) 
Upper-Airway Cough Syndrome  1  1/206 (0.49%)  0/131 (0.00%) 
Skin and subcutaneous tissue disorders     
Actinic Keratosis  1  1/206 (0.49%)  0/131 (0.00%) 
Alopecia  1  0/206 (0.00%)  1/131 (0.76%) 
Angioedema  1  0/206 (0.00%)  1/131 (0.76%) 
Blister  1  1/206 (0.49%)  0/131 (0.00%) 
Pruritus  1  0/206 (0.00%)  1/131 (0.76%) 
Rash  1  1/206 (0.49%)  1/131 (0.76%) 
Rash Maculo-Papular  1  1/206 (0.49%)  0/131 (0.00%) 
Rash Pruritic  1  0/206 (0.00%)  2/131 (1.53%) 
Skin Lesion  1  1/206 (0.49%)  0/131 (0.00%) 
Skin Swelling  1  0/206 (0.00%)  1/131 (0.76%) 
Transient Acantholytic Dermatosis  1  1/206 (0.49%)  0/131 (0.00%) 
Dermatitis  1  0/206 (0.00%)  0/131 (0.00%) 
Eczema  1  0/206 (0.00%)  0/131 (0.00%) 
Surgical and medical procedures     
Removal Of Foreign Body  1  1/206 (0.49%)  0/131 (0.00%) 
Wisdom Teeth Removal  1  0/206 (0.00%)  1/131 (0.76%) 
Vascular disorders     
Arterial Spasm  1  1/206 (0.49%)  0/131 (0.00%) 
Haematoma  1  1/206 (0.49%)  0/131 (0.00%) 
Hypertension  1  3/206 (1.46%)  6/131 (4.58%) 
Hypertensive Crisis  1  0/206 (0.00%)  1/131 (0.76%) 
Hypertensive Urgency  1  3/206 (1.46%)  1/131 (0.76%) 
Hypotension  1  2/206 (0.97%)  1/131 (0.76%) 
Iliac Artery Dissection  1  0/206 (0.00%)  1/131 (0.76%) 
Orthostatic Hypotension  1  0/206 (0.00%)  1/131 (0.76%) 
Raynaud's Phenomenon  1  1/206 (0.49%)  0/131 (0.00%) 
Vasospasm  1  1/206 (0.49%)  0/131 (0.00%) 
Arteriosclerosis  1  0/206 (0.00%)  0/131 (0.00%) 
Deep Vein Thrombosis  1  0/206 (0.00%)  0/131 (0.00%) 
1
Term from vocabulary, MedDRA (25.0)
Indicates events were collected by systematic assessment
[1]
General Disorders And Administration Site Conditions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cecile Mahoney, Principal Clinical Research Specialist
Organization: Medtronic
Phone: (763)505-1057
EMail: cecile.c.mahoney@medtronic.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439775    
Other Study ID Numbers: SPYRAL HTN-ON MED
First Submitted: April 28, 2015
First Posted: May 12, 2015
Results First Submitted: August 18, 2023
Results First Posted: September 15, 2023
Last Update Posted: November 7, 2023