Print

Purpose

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® Peripheral 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 in the US and Europe. Subjects participating in this registry will be followed through their 12-month follow up visit.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
JETi Peripheral Thrombectomy System Subjects who were treated with JETi Peripheral Thrombectomy System will be included.
  • Device: JETi Peripheral Thrombectomy System
    The JETi System is is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system is comprised 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

Vinuta Rau, PhD
+1 408-845-0864
vinuta.rau@abbott.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.