NEW DATA

JETi Peripheral Thrombectomy Registry

Background
The JETi Registry (JETi Peripheral Thrombectomy Registry NCT04370691) is an all-comers, prospective, single-arm, multicenter, post-market study designed to collect real-world data on the JETi Hydrodynamic Thrombectomy System (JETi™ System), a hydro-mechanical aspiration system intended to remove intravascular thrombus.

Methods
The JETi Registry will enroll approximately 280 all-comer patients at approximately 30 sites globally. Patients may be treated for either arterial or venous thrombosis in the peripheral vasculature and are followed for 1 year, with data collection at baseline, procedure, discharge, 30 days, and 1 year. Enrollment for the arterial cohort is complete with a total of 129 registered patients, and primary endpoint outcomes are available for these patients. Enrollment for the venous cohort is ongoing.

Endpoints
The primary endpoints for the arterial thrombosis cohort are clot removal grade (% of clot removal) for each treated vessel pre- to post-JETi™ System treatment and the composite rate of JETi™ System-related major adverse events, defined as device-related death, major amputation of the treated limb, or major bleeding, up to 30 days post-procedure. Descriptive endpoints include core lab assessed thrombo-aspiration in peripheral ischemia (TIPI) flow, ankle brachial index (ABI), Rutherford classification, and the SF-12 quality of life assessment.

Clinical Outcomes
After JETi™ System treatment and prior to any other adjunctive treatments or devices, 72.1% of treated vessels achieved 50% or more thrombus reduction with 96.1% of vessels at complete or near complete recanalization. After JETi™ System and other adjunctive treatments or devices, 94.0% of treated vessels achieved at least 50% thrombus reduction with all vessels at complete or near complete recanalization. There were 0 JETi™ System-related major adverse events or adverse events (CEC adjudicated), no device and procedure related deaths (CEC adjudicated), and a 0% re-thrombosis rate up to 30 days post-procedure. Most patients were treated in a single session (86.8% of patients) and few underwent catheter-directed thrombolysis (<15% of patients).