Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

Study Overview
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Brief Summary
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To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)

Official Title
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A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute 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. Evidence of PE must be from CTA. Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9 Patient is 18 years of age or older Exclusion Criteria: tPA use within 14 days prior to baseline CTA Systolic BP < 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg Pulmonary hypertension with peak PA > 70 mmHg by right heart catheterization History of severe or chronic pulmonary hypertension Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90% Hematocrit < 28% Platelets < 100,000µL Serum creatinine > 1.8 mg/dL INR > 3 aPTT (or PTT) > 50 seconds on no anticoagulation History of heparin-induced thrombocytopenia (HIT) Contraindication to systemic or therapeutic doses of anticoagulants Major trauma < 14 days Presence of intracardiac lead Cardiovascular or pulmonary surgery within last 7 days Cancer requiring active chemotherapy Known serious, uncontrolled sensitivity to radiographic agents Life expectancy < 90 days Female who is pregnant Intracardiac Thrombus Patients on ECMO Current participation in another investigational 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism | Device: Indigo Aspiration System<br>* use of mechanical thrombectomy to treat pulmonary embolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricle/Left Ventricle (RV:LV) Ratio | Change in RV/LV ratio per CTA | from baseline to 48 hours | 
| Major Adverse Event Rate | A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury) | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related Death Rate |  | within 48 hours | 
| Major Bleeding Rate |  | within 48 hours | 
| Clinical Deterioration Rate |  | within 48 hours | 
| Pulmonary Vascular Injury Rate |  | within 48 hours | 
| Cardiac Injury Rate |  | within 48 hours | 
| Any-cause Mortality |  | within 30 days | 
| Device-related SAE Rate |  | within 30 days | 
| Symptomatic PE Recurrence Rate |  | within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism, clot