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The First RCT Comparing CAVT + Anticoagulation to Anticoagulation Aloneb

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Prospective, Randomized Trial

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Acute, intermediate-high risk PE

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Up to 25 Sites

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100 Participants

The trial objective is to evaluate the safety and efficacy of treating acute, intermediate-high risk pulmonary embolism with anticoagulants alone versus anticoagulants plus computer assisted vacuum thrombectomy (CAVT) with the Indigo® Aspiration System.

    • Change in RV/LV ratio assessed by CTPA at 48-hours
    • Major adverse events within 7 daysa
    • Functional outcomes and quality of life assessments at 90 days

    a. Major adverse event is defined as a composite of clinical deterioration requiring escalation of care, PE-related mortality, symptomatic recurrent PE, or major bleeding.

  • STORM-PE patients will be randomized 1:1, divided into the computer assisted vacuum thrombectomy (CAVT) plus anticoagulation arm or the anticoagulation alone arm.

    Additional Wearable Device Sub-Study

    • Symptom onset of 14 days or less
    • Acute PE with proximal filing defect confirmed by CTPA
    • Intermediate-high risk PE demonstrated by RV/LV ratio and elevated biomarkers Study Site

National Principal Investigators

Rachel Rosovsky, MD


Massachusetts General Hospital

Robert Lookstein, MD

Interventional Radiology

Mount Sinai Hospital

Steering Committee Members

Ido Weinberg, MD

Vascular Medicine

Massachusetts General Hospital

Richard Channick, MD


UCLA Medical Center

John Moriarty, MD

Interventional Radiology

UCLA Medical Center

Sahil Parikh, MD

Interventional Cardiology

Columbia University Medical Center

Stavros Konstantinides, MD


University of Mainz

Suhail Dohad, MD

Interventional Cardiology

Cedars Sinai

b. ONGOING TRIAL. Comparison of two pulmonary embolism treatments – STORM-PE. Updated March 28, 2024. Accessed April 9, 2024.


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