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Comparison of Two Pulmonary Embolism Treatments

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ClinicalTrials.gov Identifier: NCT05684796
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Acute Drug: Anticoagulation Device: mechanical aspiration thrombectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization will be 1:1 to either anticoagulation alone (AC Group) or anticoagulation plus mechanical aspiration thrombectomy with the Indigo Aspiration System (Indigo Group).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STORM-PE: A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo® Aspiration System for the Treatment of Intermediate High Risk Acute Pulmonary Embolism
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : July 2026


Arm Intervention/treatment
Active Comparator: Anticoagulation (AC)
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
Drug: Anticoagulation
Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)

Active Comparator: Indigo
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
Device: mechanical aspiration thrombectomy
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Other Name: Indigo Aspiration System




Primary Outcome Measures :
  1. Change in RV/LV ratio [ Time Frame: 48 hours post-randomization ]
    Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)


Secondary Outcome Measures :
  1. Major Adverse Events [ Time Frame: within 7 days post-randomization ]
    Major adverse events (MAEs) within 7 days: a composite of clinical deterioration requiring escalation of care, PE-related mortality, symptomatic recurrent PE, or major bleeding

  2. Functional Outcome Assessment with the 6-minute walk test [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the 6-minute walk test (6MWT) through 90 days. The 6-minute walk test measures distance walked in meters, with longer distances being better.

  3. Functional Outcome Assessment with the New York Heart Association Classification [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the New York Heart Association classification (NYHA) through 90 days. The New York Heart Association classification ranges from Class I-IV, with higher classifications being worse.

  4. Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the Post Venous Thromboembolism Functional Status (PVFS) scale through 90 days. The Post Venous Thromboembolism Functional Status scale ranges from 0-5, with higher scores being worse.

  5. Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the modified Medical Research Council Dyspnea Scale (mMRC) through 90 days. The modified Medical Research Council Dyspnea Scale ranges from 0-4, with higher scores being worse.

  6. Functional Outcome Assessment with the Borg Scale [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.

  7. Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire [ Time Frame: within 90 days post-randomization ]
    Quality of Life (QoL), as assessed by the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) through 90 days. The Pulmonary Embolism Quality of Life Questionnaire measures 6 dimensions, with higher scores being worse.

  8. Quality of Life Assessment with the EQ-5D-5L Questionnaire [ Time Frame: within 90 days post-randomization ]

    Quality of Life (QoL), as assessed by the EQ-5D-5L Questionnaire through 90 days. The EQ-5D-5L Questionnaire measures 5 dimensions, with higher scores being worse.

    The Visual Analogue Scale (VAS) scale is part of the questionnaire and ranges from 0-100, with higher scores being better.


  9. All-cause Mortality [ Time Frame: within 90 days post-randomization ]
    All-cause mortality within 90 days

  10. PE-related Mortality [ Time Frame: within 90 days post-randomization ]
    PE-related mortality within 90 days

  11. Symptomatic PE Recurrence [ Time Frame: within 90 days post-randomization ]
    Symptomatic PE recurrence within 90 days



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years old
  2. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  3. Objectively confirmed acute PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
  4. Classification of intermediate high-risk PE as demonstrated by right ventricular dysfunction with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP, and/or NT-pro BNP above the upper limit of normal
  5. Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
  6. Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

  1. Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
  2. Hemodynamic instability with any of the following present:

    1. Cardiac arrest
    2. Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) <90 mmHg or an acute drop in systolic BP ≥40 mmHg for >15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg
  3. Patients on ECMO
  4. National Early Warning Score (NEWS) 2 ≥9
  5. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
  6. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
  7. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
  8. Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
  9. <45 mL/min creatinine clearance
  10. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
  11. Active bleeding or disorders contraindicating anticoagulant therapy
  12. Hemoglobin <10 g/dL
  13. Platelets <100,000/μL
  14. INR >3
  15. Patients on chronic antiplatelet or anticoagulation therapy, except low-dose acetylsalicylic acid or clopidogrel 75 mg once daily
  16. Cardiovascular or pulmonary surgery within last 7 days
  17. Active cancer or cancer/tumor requiring active therapy (surgery, chemotherapy, targeted therapy, or radiation) in the previous 6 months or during the course of the trial (other than non-melanoma skin cancer) or tumor with caval invasion
  18. Life expectancy <90 days
  19. Pregnancy
  20. Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging
  21. Current participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05684796


Contacts
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Contact: Meghan Beatty 757-759-2898 mbeatty@penumbrainc.com
Contact: Erin Archard 802-377-9715 earchard@penumbrainc.com

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
McLaren Bay Heart & Vascular Recruiting
Bay City, Michigan, United States, 48708
United States, New Jersey
Cooper Health System Recruiting
Camden, New Jersey, United States, 08103
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
United States, Tennessee
Ascension Saint Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Rachel Rosovsky, MD Massachusetts General Hospital
Principal Investigator: Robert Lookstein, MD MOUNT SINAI HOSPITAL
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT05684796    
Other Study ID Numbers: 18190
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Penumbra Inc.:
intermediate-high risk
acute
PE
clot
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases