JETi Lower Extremity Venous Thrombosis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

30 sites in 4 countries.

About this study

Official title: JETi Enhanced Thrombectomy Intervention Registry - JETi Registry

Conditions

Venous Thrombosis

Being tested

JETi lower extremity venous thrombosis

Keywords

ABT - CIP -10433, Venous Thrombosis, Thrombectomy intervention

Medical subject headings

Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• JETi lower extremity venous thrombosisDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   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.

   Measured: 30 days

2. The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 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

   Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Jun 2025
2. Study start3 Aug 2020
3. Primary completion1 Aug 2024
4. Study completion16 Jul 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Venous ThrombosisStudies of the same condition, open and under way.
• More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.