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

Study Overview
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Brief Summary
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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).

Official Title
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STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Indigo Aspiration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Informed consent obtained per Institutional Review Board/Ethics Committee requirements Exclusion Criteria: Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study Known serious, uncontrolled sensitivity to radiographic agents Life expectancy < 180 days Patients on ECMO Pregnant patients Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute pulmonary embolism<br> | Device: Indigo Aspiration System<br>* Indigo Aspiration System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 hours | 
| Performance: Change in RV/LV Ratio | Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available) | 48 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessed via PEmb-QoL | Self-assessment of PE related complaints and daily living limitations (including work and social) | 90 days post-procedure | 
| Quality of Life assessed via EQ-5D-5L | Self-assessment of activities of daily living | 90 days post-procedure | 
| Functional outcome assessed NYHA | Physician assessment of heart failure symptoms and activity level | 90 days post-procedure | 
| Functional outcome assessed via 6MWT | Walking distance over a 6 minute period to assess functional capacity | 90 days post-procedure | 
| Perceived dyspnea assessed via Borg Scale | Category rating scale to measure perceived dyspnea | 90 days post-procedure | 
| Incidence of device related SAE(s) |  | 365 days | 
| Any-cause mortality |  | Within 30 days | 
| Symptomatic PE recurrence |  | Within 30 days |