Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
NCT ID: NCT03218566
Last Updated: 2020-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2017-11-22
2019-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System
use of mechanical thrombectomy to treat pulmonary embolism
Interventions
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Indigo Aspiration System
use of mechanical thrombectomy to treat pulmonary embolism
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Akhilesh Sista, MD
Role: PRINCIPAL_INVESTIGATOR
NYU-Langone School of Medicine
Locations
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Banner University Medical Center - Tucson
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
St. Joseph Health Hospital
Orange, California, United States
Christiana Care
Newark, Delaware, United States
Baptist Hospital of Miami
Miami, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Our Lady of the Lake Hospital Inc.
Baton Rouge, Louisiana, United States
Detroit Medical Center
Detroit, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mercy Hospital South
St Louis, Missouri, United States
New York University (NYU) Langone Medical Center
New York, New York, United States
Mount Sinai
New York, New York, United States
North Carolina Heart and Vascular Research (NCHVR)
Raleigh, North Carolina, United States
University of Pennsylvania Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Sanford Health
Sioux Falls, South Dakota, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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11373
Identifier Type: -
Identifier Source: org_study_id
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