JETi Lower Extremity Arterial Thrombosis

Active, not recruiting

Conditions: Arterial Thrombosis

Interventions: Device: JETi Peripheral Thrombectomy System

Registration Number: NCT04370691

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 129

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JETi™ Hydrodynamic Thrombectomy System	JETi Peripheral Thrombectomy System	Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis	Baseline	Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) per the grades. The independent imaging core laboratory will be responsible for assessing this endpoint. The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below: * Grade I: \< 50% reduction * Grade II: 50- \<95% reduction * Grade III: 95-100% reduction
Primary Safety Endpoint - Composite Rate of JETi-related MAEs	Up to 30 days post-JETi procedure	JETi-related events defined as device-related death, major amputation of the treated limb, or major bleeding up to 30 days post-JETi procedure and as adjudicated by a clinical events committee (CEC).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (30): Southoast Hospital
🇺🇸
Fall River, Massachusetts, United States
Hôpital Saint-François d'Assise
🇨🇦
Québec, Quebec, Canada
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
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
University Hospital Aachen
🇩🇪
Aachen, Nordrhein Westfalen, Germany
Marien Hospital Herne
🇩🇪
Herne, Nordrhein Westfalen, Germany
Klinikum Hochsauerland
🇩🇪
Arnsberg, Germany
Evangelisches Krankenhaus Königin Elisabeth Herzberge
🇩🇪
Berlin, Germany
Sankt Gertrauden Krankenhaus
🇩🇪
Berlin, Germany
Universitätsklinikum Giessen
🇩🇪
Gießen, Germany
Medizinische Einrichtungen der Universität zu Köln
🇩🇪
Köln, Germany