Clinical Trials Directory

Trials / Completed

CompletedNCT04370691

JETi Lower Extremity Arterial Thrombosis

JET Enhanced Thrombectomy Intervention Registry - JETi Registry

Status
Completed
Phase
Study type
Observational
Enrollment
129 (actual)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study 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.

Conditions

Interventions

TypeNameDescription
DEVICEJETi lower extremity arterial thrombosisThe JETi System is 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.

Timeline

Start date
2020-03-06
Primary completion
2024-01-16
Completion
2024-10-09
First posted
2020-05-01
Last updated
2025-06-17
Results posted
2025-03-03

Locations

30 sites across 4 countries: United States, Australia, Canada, Germany

Source: ClinicalTrials.gov record NCT04370691. Inclusion in this directory is not an endorsement.