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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenumbra Inc.

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).

Eligibility criteria

Qualifiers

Clinical signs and symptoms consistent with acute PE with duration of 14 days or less

RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram

Frontline endovascular treatment with the Indigo Aspiration System per IFU

Patient is ≥ 18 years of age

Disqualifiers

Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)

Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation

Known serious, uncontrolled sensitivity to radiographic agents

Life expectancy < 180 days

Trial design

Treatments tested in this trial

  • Indigo Aspiration System

Treatment groups

1,500 Participants
are divided into 1 treatment group

Sponsors and collaborators