Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism (EXTRACT-PE)

Penumbra

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Device: Indigo Aspiration System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218566

11373

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Single Arm

Other group

Description:

Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism

Treatment:

Device: Indigo Aspiration System