Comparison of Two Pulmonary Embolism Treatments

• ClinicalTrials.gov Identifier: NCT05684796
• Recruitment Status: Recruiting
• First Posted: January 13, 2023
• Last Update Posted: August 29, 2023
• Sponsor: Penumbra Inc.
• Information provided by (Responsible Party): Penumbra Inc.

Study Description

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

Study Design

• 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
• Estimated Study Start Date: August 2023
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: July 2026

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Meghan Beatty; 757-759-2898; mbeatty@penumbrainc.com

Contact: Erin Archard; 802-377-9715; earchard@penumbrainc.com

Locations

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, Tennessee

Ascension Saint Thomas Hospital; Recruiting

Nashville, Tennessee, United States, 37205

Sponsors and Collaborators

Penumbra Inc.

Investigators

• Principal Investigator: Rachel Rosovsky, MD; Massachusetts General Hospital
• Principal Investigator: Robert Lookstein, MD; MOUNT SINAI HOSPITAL

More Information

• Responsible Party: Penumbra Inc.
• ClinicalTrials.gov Identifier: NCT05684796
• Other Study ID Numbers: 18190
• First Posted: January 13, 2023
• Last Update Posted: August 29, 2023
• Last Verified: August 2023

• 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:

Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases