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
1 other identifier
interventional
119
1 country
22
Brief Summary
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2019
CompletedResults Posted
Study results publicly available
August 3, 2020
CompletedAugust 3, 2020
July 1, 2020
1.3 years
July 6, 2017
March 24, 2020
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Single Arm
OTHERSingle Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (22)
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
St. Joseph Health Hospital
Orange, California, 92868, United States
Christiana Care
Newark, Delaware, 19713, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Our Lady of the Lake Hospital Inc.
Baton Rouge, Louisiana, 70808, United States
Detroit Medical Center
Detroit, Michigan, 48201, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
New York University (NYU) Langone Medical Center
New York, New York, 10016, United States
Mount Sinai
New York, New York, 10029, United States
North Carolina Heart and Vascular Research (NCHVR)
Raleigh, North Carolina, 27607, United States
University of Pennsylvania Medical Center (UPMC)
Pittsburgh, Pennsylvania, 16148, United States
Sanford Health
Sioux Falls, South Dakota, 57117, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25309, United States
Related Publications (2)
Jorge JV, Barreiros CA, Silva D, Cale R, Ribeiro JM. Extracorporeal mechanical support and aspiration thrombectomy in treatment of massive pulmonary embolism: a case report. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):524-528. doi: 10.5935/0103-507X.20220342-pt. Epub 2023 Mar 3.
PMID: 36888834DERIVEDSista 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.
PMID: 33454291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erin Archard, Sr. Clinical Study Manager
- Organization
- Penumbra, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Akhilesh Sista, MD
NYU-Langone School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 14, 2017
Study Start
November 22, 2017
Primary Completion
March 10, 2019
Study Completion
April 5, 2019
Last Updated
August 3, 2020
Results First Posted
August 3, 2020
Record last verified: 2020-07