JETi Lower Extremity Arterial Thrombosis (JETi)

JET Enhanced Thrombectomy Intervention Registry - JETi Registry

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.

Study Overview

• Status: Completed
• Conditions: Arterial Thrombosis
• Intervention / Treatment: Device: JETi lower extremity arterial thrombosis

Detailed Description

The JETi Registry will collect data on how the JETi System performs in the standard of care treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral arterial and venous thrombosis. The study will register approximately 250 subjects at up to 30 centers in the US and EU. Subjects will be followed up to 12 months post-procedure per site standard of care, with data collection at discharge, 30 days, 6 months, and up to 12 months when available.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia, 6000
    • Royal Perth Hospital
• Canada
  • Quebec
    • Québec, Quebec, Canada, G1L 3L5
      • Hôpital Saint-François d'Assise
• Germany
  • Arnsberg, Germany, 59759
    • Klinikum Hochsauerland
  • Berlin, Germany, 10365
    • Evangelisches Krankenhaus Königin Elisabeth Herzberge
  • Berlin, Germany, 10713
    • Sankt Gertrauden Krankenhaus
  • Gießen, Germany, 35392
    • Universitätsklinikum Giessen
  • Köln, Germany, 50937
    • Medizinische Einrichtungen der Universität zu Köln
  • Nordrhein Westfalen
    • Aachen, Nordrhein Westfalen, Germany, 52074
      • University Hospital Aachen
    • Herne, Nordrhein Westfalen, Germany, 44625
      • Marien Hospital Herne
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Honor Health
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart
  • California
    • Los Angeles, California, United States, 90017
      • PIH Good Samaritan
    • Los Angeles, California, United States, 90095
      • Cedars Sinai Medical Center
    • Palo Alto, California, United States, 94305
      • Stanford University Hospital and Clinics
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Thornton, Colorado, United States, 80023
      • ClinRé
  • Indiana
    • Hobart, Indiana, United States, 46342
      • St. Mary Medical Center
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Massachusetts
    • Fall River, Massachusetts, United States, 02740
      • Southoast Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Detroit
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Ascension St. John Jane Phillips
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. 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.
2. Subject or legally authorized representative must provide written informed consent.
3. Subject must be ≥ 18 years of age

Exclusion Criteria:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Lower Extremity; ABT-CIP-10433; Arterial Thrombosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: ABT-CIP-10433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No