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