Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Recruiting
Observational Study
Pulmonary Embolism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,500 (estimated)
- Sponsor
- Penumbra Inc. · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
4. Patient …
Contacts