Trials / Completed
CompletedNCT05684796
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Penumbra Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anticoagulation | Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) |
| DEVICE | mechanical aspiration thrombectomy | Mechanical aspiration thrombectomy with the Indigo Aspiration System. |
Timeline
- Start date
- 2023-11-27
- Primary completion
- 2025-06-12
- Completion
- 2025-09-09
- First posted
- 2023-01-13
- Last updated
- 2025-11-17
Locations
22 sites across 4 countries: United States, Canada, New Zealand, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05684796. Inclusion in this directory is not an endorsement.