JETi Lower Extremity Arterial Thrombosis

Completed

Conditions studied: Arterial Thrombosis

In brief

The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study will register approximately 280 subjects at approximately 30 centers Globally. Subjects participating in this Registry will be followed through their 12-month follow up visit.

Key facts

Study ID

NCT04370691

Run by

Abbott Medical Devices

People needed

129

Starts

2020-03-06

Expected to finish

2024-10-09

Last updated by the study team

2025-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the investigator, in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
• Subject or legally authorized representative must provide written informed consent.
• Subject must be ≥ 18 years of age

You may not qualify if…

• Subject has previously been registered in the JETi Registry in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study.
• Subject is currently participating in another drug or device clinical investigation.
• 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.

Where it is running

• 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
• ClinRé — 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

Full record on ClinicalTrials.gov

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