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

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)

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Indigo Aspiration System

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Orange, California, United States, 92868
      • St. Joseph Health Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Hospital Inc.
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Mercy Hospital South
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
    • New York, New York, United States, 10016
      • New York University (NYU) Langone Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular Research (NCHVR)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 16148
      • University of Pennsylvania Medical Center (UPMC)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford Health
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists
  • West Virginia
    • Charleston, West Virginia, United States, 25309
      • Charleston Area Medical Center (CAMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Akhilesh Sista, MD, NYU-Langone School of Medicine

Publications and helpful links

General Publications

• Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pulmonary embolism; clot
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 11373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes