Trials / Recruiting
RecruitingNCT04798261
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,500 (estimated)
- Sponsor
- Penumbra Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Indigo Aspiration System | Indigo Aspiration System |
Timeline
- Start date
- 2021-06-25
- Primary completion
- 2026-12-01
- Completion
- 2028-02-01
- First posted
- 2021-03-15
- Last updated
- 2026-04-14
Locations
74 sites across 11 countries: United States, Australia, Brazil, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04798261. Inclusion in this directory is not an endorsement.