JETi Lower Extremity Venous Thrombosis

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Perth Hospital, Perth, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JETi lower extremity venous thrombosis

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.

Primary outcomes

The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final)

Time frame: 30 days

The percent of treated vessel(s) with ≥ 75% venous thrombus reduction from pre-JETi venogram to final venogram (post-JETi and after any/all adjunctive therapies to treat underlying culprit lesions) via modified Marder score.

Marder Score Reduction is calculated using the formula below: [(Pre-JETi Marder Score - final Marder Score) / Pre-JETi Marder Score] x 100.

Modified Marder Score is a calculation based on summation of gradient thrombus burden at the following venous segments: iliac, common femoral, femoral and popliteal. Modified Marder score is based on total score of all imaged and assessed venous segments (including iliac, common femoral, femoral and popliteal) at that specific timepoint. Each limb can only have one modified Marder score.
The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 30 Days

Time frame: 30 days

The composite of JETi-related MAEs (death, symptomatic pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-treated vessel(s) up to 30 days post-JETi procedure for subjects treated for lower extremity DVT and as adjudicated by a CEC

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

JETi Enhanced Thrombectomy Intervention Registry - JETi Registry

Acronym: JETiRegistry

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2025
First posted: Jun 19, 2025
Registry last updated: Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed