Study Results
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View full resultsBasic Information
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COMPLETED
129 participants
OBSERVATIONAL
2020-03-06
2024-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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JETi™ Hydrodynamic Thrombectomy System
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
JETi lower extremity arterial thrombosis
The JETi System is is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system comprises of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Interventions
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JETi lower extremity arterial thrombosis
The JETi System is is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system comprises of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Eligibility Criteria
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Inclusion Criteria
2. Subject or legally authorized representative must provide written informed consent.
3. Subject must be ≥ 18 years of age
Exclusion Criteria
2. Subject is currently participating in another drug or device clinical investigation.
3. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the past 20 days.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Honor Health
Scottsdale, Arizona, United States
Arkansas Heart
Little Rock, Arkansas, United States
PIH Good Samaritan
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford University Hospital and Clinics
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
ClinRĂ©
Thornton, Colorado, United States
St. Mary Medical Center
Hobart, Indiana, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Southoast Hospital
Fall River, Massachusetts, United States
Henry Ford Detroit
Detroit, Michigan, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Hendrick Medical Center
Abilene, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Royal Perth Hospital
Perth, , Australia
Hôpital Saint-François d'Assise
Québec, Quebec, Canada
University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Marien Hospital Herne
Herne, North Rhine-Westphalia, Germany
Klinikum Hochsauerland
Arnsberg, , Germany
Evangelisches Krankenhaus Königin Elisabeth Herzberge
Berlin, , Germany
Sankt Gertrauden Krankenhaus
Berlin, , Germany
Medizinische Einrichtungen der Universität zu Köln
Cologne, , Germany
Universitätsklinikum Giessen
Giessen, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10433
Identifier Type: -
Identifier Source: org_study_id
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