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Clinical Trial ● Currently Recruiting NCT04798261

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System — Recruiting • Cardiology / Cardiovascular • NCT04798261.

📅 14 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
NCT ID
NCT04798261
Sponsor
Penumbra Inc.
Start
2021-06-25
ClinicaliQ Trial Snapshot
  • Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System — Recruiting • Cardiology / Cardiovascular • NCT04798261.
  • What is being tested: Long-term safety, performance, and functional outcomes of the Indigo Aspiration System, a mechanical thrombectomy device designed to remove blood clots in patients with pulmonary embolism.
  • Patient eligibility overview: The study enrolls patients with pulmonary embolism who are candidates for treatment with the Indigo Aspiration System, assessed according to standard clinical criteria for mechanical thrombectomy.
Use This Page For
  • 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.
What This Trial Is Studying

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).

Eligibility Snapshot
  • : 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.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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