JETi Lower Extremity Venous Thrombosis

NCT ID: NCT07027878

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2025-08-31

Brief Summary

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The JETi Registry is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that 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

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Conditions

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Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 venous thrombosis

Intervention Type DEVICE

The JETi System 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 venous thrombosis

The JETi System 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HonorHealth

Scottsdale, Arizona, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

PIH Good Samaritan

Los Angeles, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Stanford University Hospital and Clinics

Palo Alto, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

ClinRé

Thornton, Colorado, United States

Site Status

St. Mary Medical Center

Hobart, Indiana, United States

Site Status

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Southoast Hospital

Fall River, Massachusetts, United States

Site Status

Henry Ford Detroit

Detroit, Michigan, United States

Site Status

St. Luke's Hospital

Kansas City, Missouri, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, United States

Site Status

Hightower Clinical

Oklahoma City, Oklahoma, United States

Site Status

Hendrick Medical Center

Abilene, Texas, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Royal Perth Hospital

Perth, , Australia

Site Status

Hôpital Saint-François d'Assise

Québec, Quebec, Canada

Site Status

University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Marien Hospital Herne

Herne, North Rhine-Westphalia, Germany

Site Status

Klinikum Hochsauerland

Arnsberg, , Germany

Site Status

Evangelisches Krankenhaus Königin Elisabeth Herzberge

Berlin, , Germany

Site Status

Sankt Gertrauden Krankenhaus

Berlin, , Germany

Site Status

Medizinische Einrichtungen der Universität zu Köln

Cologne, , Germany

Site Status

Universitätsklinikum Giessen

Giessen, , Germany

Site Status

Countries

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United States Australia Canada Germany

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ABT-CIP-10433 Venous

Identifier Type: -

Identifier Source: org_study_id

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