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

A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

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

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