Comparison of Two Pulmonary Embolism Treatments

NCT ID: NCT05684796

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2025-09-09

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).

Conditions

Pulmonary Embolism Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anticoagulation (AC)

Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.

Group Type: ACTIVE_COMPARATOR

Anticoagulation

Intervention Type: DRUG

Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)

Indigo

Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.

Group Type: ACTIVE_COMPARATOR

mechanical aspiration thrombectomy

Intervention Type: DEVICE

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Interventions

Anticoagulation

Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)

Intervention Type: DRUG

mechanical aspiration thrombectomy

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Intervention Type: DEVICE

Other Intervention Names

Indigo Aspiration System

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. Cardiovascular or pulmonary surgery within last 7 days

16. Primary brain or metastatic brain cancer

17. Life expectancy <90 days

18. Pregnancy

19. Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging

20. 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.

21. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the trial, including compliance with follow-up requirements, or that could impact the scientific integrity of the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Rosovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Robert Lookstein, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

The University of Arizona - Banner

Tucson, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Radiology and Imaging Specialists/Lakeland Regional

Lakeland, Florida, United States

Joseph Maxwell Cleland Atlanta VA Medical Center

Decatur, Georgia, United States

Wellstar Kennestone

Marietta, Georgia, United States

Northwestern Memorial

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

McLaren Bay Heart & Vascular

Bay City, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Cooper Health System

Camden, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

Ascension Seton Medical Center Austin

Austin, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

Kingwood Medical Center

Kingwood, Texas, United States

Metropolitan Methodist Hospital

San Antonio, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Foothills Medical Centre

Calgary, Alberta, Canada

Auckland City Hospital

Auckland, , New Zealand

Krakowski Szpital Specjalistyczny św. Jana Pawła II

Krakow, , Poland

Countries

United States; Canada; New Zealand; Poland

References

Rosovsky RP, Konstantinides SV, Moriarty JM, Dohad SY, Weinberg I, Parikh SA, Channick R, Lookstein RA. A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study. Am Heart J. 2025 Oct;288:1-14. doi: 10.1016/j.ahj.2025.03.018. Epub 2025 Mar 31.

Reference Type: DERIVED

PMID: 40174693 (View on PubMed)

Other Identifiers

18190

Identifier Type: -

Identifier Source: org_study_id