Comparison of Two Pulmonary Embolism Treatments

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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Drug: Anticoagulation; Device: mechanical aspiration thrombectomy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• Poland
  • Krakow, Poland
    • Krakowski Szpital Specjalistyczny św. Jana Pawła II
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • The University of Arizona - Banner
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90024
      • UCLA Medical Center
  • Florida
    • Lakeland, Florida, United States, 33801
      • Radiology and Imaging Specialists/Lakeland Regional
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Joseph Maxwell Cleland Atlanta VA Medical Center
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Edgewood Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Heart & Vascular
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health William Beaumont University Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Ascension Seton Medical Center Austin
    • Dallas, Texas, United States, 75226
      • Baylor University Medical Center
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
    • San Antonio, Texas, United States, 78212
      • Metropolitan Methodist Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Indigo Aspiration System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in RV/LV Ratio	Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.	48 hours post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	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	within 7 days post-randomization
All-cause Mortality	All-cause mortality within 90 days	within 90 days post-randomization
PE-related Mortality	PE-related mortality within 90 days	within 90 days post-randomization
Symptomatic PE Recurrence	Symptomatic PE recurrence within 90 days	within 90 days post-randomization
Functional Outcome Assessment With the 6-minute Walk Test	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.	Through 90 days post-randomization
Functional Outcome Assessment With the New York Heart Association Classification	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 (no limitations) -IV (severe limitation), with higher classifications being worse.	Through 90 days post-randomization
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale	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.	Through 90 days post-randomization
Functional Outcome Assessment With the Modified Medical Research Council Dyspnea Scale	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.	Through 90 days post-randomization
Functional Outcome Assessment With the Borg Scale	Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.	Through 90 days post-randomization
Quality of Life Assessment With the Pulmonary Embolism Quality of Life Questionnaire	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 the percent of life affected by PE across 6 dimensions (including: Frequency of complaints, Limitations in activities of daily living (ADL), Work-related problems, Social limitations, Intensity of complaints, Emotional complaints), with higher scores being worse.	Through 90 days post-randomization
Quality of Life Assessment With the EQ-5D-5L Questionnaire	Quality of Life (QoL), as assessed by the EQ-5D-5L Questionnaire through 90 days. The EQ-5D-5L index is a preference-weighted measure of health status derived from five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Index values represent overall health status, with higher scores indicating better health status. The Visual Analogue Scale (VAS) scale is part of the questionnaire and ranges from 0-100, with higher scores being better.	Through 90 days post-randomization

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Rachel Rosovsky, MD, Massachusetts General Hospital; Principal Investigator: Robert Lookstein, MD, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.
• Lookstein RA, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Kopec G, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Yamada K, Rosovsky RP; STORM-PE Trial Investigators. Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial. Circulation. 2026 Jan 6;153(1):21-34. doi: 10.1161/CIRCULATIONAHA.125.077232. Epub 2025 Nov 3.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): September 9, 2025

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: acute; PE; clot; intermediate-high risk
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: 18190

Drug and device information, study documents

• 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