JETi Lower Extremity Arterial Thrombosis

NCT04370691 | Completed Results DMC

• 1 other identifier: ABT-CIP-10433
• Study Type: observational
• Target: 129
• Locations: 4 countries
• Sites: 30

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.

Conditions

Arterial Thrombosis

Keywords

ABT-CIP-10433; Arterial Thrombosis; Lower Extremity

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis

  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

  Baseline

• Primary Safety Endpoint - Composite Rate of JETi-related MAEs

  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).

  Up to 30 days post-JETi procedure

Study Arms (1)

JETi™ Hydrodynamic Thrombectomy System

Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.

Device: JETi lower extremity arterial thrombosis

Interventions

JETi lower extremity arterial thrombosis DEVICE

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.

JETi™ Hydrodynamic Thrombectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (30)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Arkansas Heart

Little Rock, Arkansas, 72211, United States

Location

PIH Good Samaritan

Los Angeles, California, 90017, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90095, United States

Location

Stanford University Hospital and Clinics

Palo Alto, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

ClinRé

Thornton, Colorado, 80023, United States

Location

St. Mary Medical Center

Hobart, Indiana, 46342, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Southoast Hospital

Fall River, Massachusetts, 02740, United States

Location

Henry Ford Detroit

Detroit, Michigan, 48202, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44195, United States

Location

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, 74006, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

Hendrick Medical Center

Abilene, Texas, 79601, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Hôpital Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Marien Hospital Herne

Herne, North Rhine-Westphalia, 44625, Germany

Location

Klinikum Hochsauerland

Arnsberg, 59759, Germany

Location

Evangelisches Krankenhaus Königin Elisabeth Herzberge

Berlin, 10365, Germany

Location

Sankt Gertrauden Krankenhaus

Berlin, 10713, Germany

Location

Medizinische Einrichtungen der Universität zu Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Giessen

Giessen, 35392, Germany

Location

Results Point of Contact

• Title: Vinuta Rau
• Organization: Abbott

vinuta.rau@abbott.com

+ 1 408-834-0621

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 1, 2020
• Study Start: March 6, 2020
• Primary Completion: January 16, 2024
• Study Completion: October 9, 2024
• Last Updated: June 17, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21); AU (1); DE (7); CA (1)