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

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)

- Major trauma <14 days

- Cardiovascular or pulmonary surgery within last 7 days

- Cancer which requires 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