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).
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
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
Patients with acute pulmonary embolism
Cohort
Prospective
Indigo Aspiration System
DeviceIndigo Aspiration System
Safety: Composite of major adverse events
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Performance: Change in RV/LV Ratio
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
Quality of Life assessed via PEmb-QoL
Self-assessment of PE related complaints and daily living limitations (including work and social)
Quality of Life assessed via EQ-5D-5L
Self-assessment of activities of daily living
Functional outcome assessed NYHA
Physician assessment of heart failure symptoms and activity level
Functional outcome assessed via 6MWT
Walking distance over a 6 minute period to assess functional capacity
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