JETi Lower Extremity Venous Thrombosis (JETiRegistry)

Abbott

Status: Active, not recruiting

Conditions: Venous Thrombosis

Treatments: Device: JETi lower extremity venous thrombosis

Study type: Observational

Funder types: Industry

Identifiers

NCT07027878

ABT-CIP-10433 Venous

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Subject or legally authorized representative must provide written informed consent.
3. Subject must be ≥ 18 years of age.

Exclusion criteria

1. 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.
2. Subject is currently participating in another drug or device clinical investigation.
3. 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.

Trial design

121 participants in 1 patient group

JETi™ Hydrodynamic Thrombectomy System

Description:

Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.

Treatment:

Device: JETi lower extremity venous thrombosis