Comparison of Two Pulmonary Embolism Treatments

• ClinicalTrials.gov Identifier: NCT05684796
• Recruitment Status: Recruiting
• First Posted: January 13, 2023
• Last Update Posted: November 22, 2023
• Sponsor: Penumbra Inc.
• Information provided by (Responsible Party): Penumbra Inc.

Tracking Information

• First Submitted Date: December 16, 2022
• First Posted Date: January 13, 2023
• Last Update Posted Date: November 22, 2023
• Estimated Study Start Date: November 2023
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2023)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 12, 2023)

• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• All-cause Mortality [ Time Frame: within 90 days post-randomization ]
  All-cause mortality within 90 days
• PE-related Mortality [ Time Frame: within 90 days post-randomization ]
  PE-related mortality within 90 days
• Symptomatic PE Recurrence [ Time Frame: within 90 days post-randomization ]
  Symptomatic PE recurrence within 90 days

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Two Pulmonary Embolism Treatments
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Pulmonary Embolism Acute

Intervention

• Drug: Anticoagulation
  Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
• Device: mechanical aspiration thrombectomy
  Mechanical aspiration thrombectomy with the Indigo Aspiration System.
  Other Name: Indigo Aspiration System

Study Arms

• Active Comparator: Anticoagulation (AC)
  Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
  Intervention: Drug: Anticoagulation
• Active Comparator: Indigo
  Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
  Intervention: Device: mechanical aspiration thrombectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 12, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2026
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05684796
• Other Study ID Numbers: 18190
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Penumbra Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Penumbra Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Penumbra Inc.
• Verification Date: November 2023