CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Anticoagulation +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05684796
NCT05684796N/ACompleted
CompareCT.gov

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

Penumbra Inc.·interventional·Posted Jan 13, 2023·Updated Nov 17, 2025

In Brief

A clinical study evaluating Anticoagulation and mechanical aspiration thrombectomy for Pulmonary Embolism Acute. Completed, enrolled 100 participants across 22 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism Acute
CountriesCanada, New Zealand, Poland, United States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 13, 2023
Enrollment StartNov 27, 2023
Primary CompletionJun 12, 2025
Study CompletionSep 9, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.5 years ago

Interventions

Anticoagulationdrug

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

mechanical aspiration thrombectomydevice

Mechanical aspiration thrombectomy with the Indigo Aspiration System.