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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indigo Aspiration System
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring pulmonary embolism, clot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Banner University Medical Center - Tucson
  • Cedars-Sinai Medical Center
  • UCLA Medical Center
  • St. Joseph Health Hospital
  • Christiana Care
  • Baptist Hospital of Miami
  • AdventHealth Tampa
  • Grady Health System
  • Rush University Medical Center
  • University of Chicago
  • University of Kansas Medical Center
  • Our Lady of the Lake Hospital Inc.
  • Detroit Medical Center
  • University of Minnesota Medical Center
  • Mercy Hospital South
  • New York University (NYU) Langone Medical Center
  • Mount Sinai
  • North Carolina Heart and Vascular Research (NCHVR)
  • University of Pennsylvania Medical Center (UPMC)
  • Sanford Health
  • Sentara Vascular Specialists
  • Charleston Area Medical Center (CAMC)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Right Ventricle/Left Ventricle (RV:LV) Ratio
Change in RV/LV ratio per CTA
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)

Secondary Outcome Measures

Device-related Death Rate
Major Bleeding Rate
Clinical Deterioration Rate
Pulmonary Vascular Injury Rate
Cardiac Injury Rate
Any-cause Mortality
Device-related SAE Rate
Symptomatic PE Recurrence Rate

Full Information

First Posted
July 6, 2017
Last Updated
July 30, 2020
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03218566
Brief Title
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Acronym
EXTRACT-PE
Official Title
A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
March 10, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, clot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Intervention Type
Device
Intervention Name(s)
Indigo Aspiration System
Intervention Description
use of mechanical thrombectomy to treat pulmonary embolism
Primary Outcome Measure Information:
Title
Right Ventricle/Left Ventricle (RV:LV) Ratio
Description
Change in RV/LV ratio per CTA
Time Frame
from baseline to 48 hours
Title
Major Adverse Event Rate
Description
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Time Frame
within 48 hours
Secondary Outcome Measure Information:
Title
Device-related Death Rate
Time Frame
within 48 hours
Title
Major Bleeding Rate
Time Frame
within 48 hours
Title
Clinical Deterioration Rate
Time Frame
within 48 hours
Title
Pulmonary Vascular Injury Rate
Time Frame
within 48 hours
Title
Cardiac Injury Rate
Time Frame
within 48 hours
Title
Any-cause Mortality
Time Frame
within 30 days
Title
Device-related SAE Rate
Time Frame
within 30 days
Title
Symptomatic PE Recurrence Rate
Time Frame
within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akhilesh Sista, MD
Organizational Affiliation
NYU-Langone School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
St. Joseph Health Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AdventHealth Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Our Lady of the Lake Hospital Inc.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
New York University (NYU) Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
North Carolina Heart and Vascular Research (NCHVR)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
University of Pennsylvania Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Charleston Area Medical Center (CAMC)
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33454291
Citation
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.
Results Reference
derived

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

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