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.
Study Type
OBSERVATIONAL
Enrollment
121
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.
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.
Time frame: 30 days
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
Time frame: 30 days
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