The First RCT Comparing CAVT + Anticoagulation to Anticoagulation Aloneb
Prospective, Randomized Trial
Acute, intermediate-high risk PE
Up to 25 Sites
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.
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- Change in RV/LV ratio assessed by CTPA at 48-hours
- Major adverse events within 7 daysa
- Functional outcomes and qualify 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.
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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
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- 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
ClinicalTrials.gov Study Site
National Principal Investigators
Massachusetts General Hospital Rachel Rosovsky, MD
Hematology
Mount Sinai Hospital Robert Lookstein, MD
Interventional Radiology
Steering Committee Members
Massachusetts General Hospital Ido Weinberg, MD
Vascular Medicine
UCLA Medical Center Richard Channick, MD
Pulmonology
UCLA Medical Center John Moriarty, MD
Interventional Radiology
Columbia University Medical Center Sahil Parikh, MD
Interventional Cardiology
University of Mainz Stavros Konstantinides, MD
Cardiology
Cedars Sinai Suhail Dohad, MD
Interventional Cardiology
b. ONGOING TRIAL. Comparison of two pulmonary embolism treatments – STORM-PE. ClinicalTrials.gov. Updated March 28, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT05684796.