Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

JET Enhanced Thrombectomy Intervention Registry - JETi Registry

Keywords

Peripheral Artery Thrombosis, Peripheral Venous Thrombosis, ABT-CIP-10433, JETi Peripheral Thrombectomy System, Thrombosis, Venous Thrombosis, JETi™ Hydrodynamic Thrombectomy System

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • Cedars Sinai Medical Center
    Los Angeles California 90095 United States
  • PIH Good Samaritan
    Los Angeles California 90017 United States
  • Stanford University Hospital and Clinics
    Palo Alto California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04370691
Study Type
Observational [Patient Registry]
Participants
About 260 people participating
Last Updated