JETi Lower Extremity Arterial Thrombosis

Abbott

Status: Active, not recruiting

Conditions: Arterial Thrombosis

Treatments: Device: JETi lower extremity arterial thrombosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04370691

ABT-CIP-10433

Details and patient eligibility

About

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.

Enrollment: 129 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

129 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 arterial thrombosis