- Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System — Recruiting • Cardiology / Cardiovascular • NCT04798261.
- Sponsor: Penumbra Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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).
- : 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
- Patient is ≥ 18 years of age 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.