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.
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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

Joanne Krasnoff

650-455-4462

jkrasnoff@penumbrainc.com

CONTACT

Aisha Pascua

415-601-9561

apascua@penumbrainc.com

CONTACT