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

Pulmonary Embolism Clinical Trial

— EXTRACT-PE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218566
• Other study ID #: 11373
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: July 2020
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 5, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Indigo Aspiration System
use of mechanical thrombectomy to treat pulmonary embolism

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Our Lady of the Lake Hospital Inc.	Baton Rouge	Louisiana
United States	Charleston Area Medical Center (CAMC)	Charleston	West Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Detroit Medical Center	Detroit	Michigan
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Mount Sinai	New York	New York
United States	New York University (NYU) Langone Medical Center	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	St. Joseph Health Hospital	Orange	California
United States	University of Pennsylvania Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	North Carolina Heart and Vascular Research (NCHVR)	Raleigh	North Carolina
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Sanford Health	Sioux Falls	South Dakota
United States	AdventHealth Tampa	Tampa	Florida
United States	Banner University Medical Center - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right Ventricle/Left Ventricle (RV:LV) Ratio	Change in RV/LV ratio per CTA	from baseline to 48 hours
Primary	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	Device-related Death Rate		within 48 hours
Secondary	Major Bleeding Rate		within 48 hours
Secondary	Clinical Deterioration Rate		within 48 hours
Secondary	Pulmonary Vascular Injury Rate		within 48 hours
Secondary	Cardiac Injury Rate		within 48 hours
Secondary	Any-cause Mortality		within 30 days
Secondary	Device-related SAE Rate		within 30 days
Secondary	Symptomatic PE Recurrence Rate		within 30 days