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JETi Peripheral Thrombectomy Registry (JETi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370691
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The JETi Registry is a prospective, multi-center, observational 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.

Condition or disease Intervention/treatment
Peripheral Artery Thrombosis Venous Thrombosis Device: JETi Peripheral Thrombectomy System

Detailed Description:
The JETi Registry will collect data on how the JETi System performs in the standard of care treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral arterial and venous thrombosis. The study will register approximately 250 subjects at up to 30 centers in the US and EU. Subjects will be followed up to 12 months post-procedure per site standard of care, with data collection at discharge, 30 days, 6 months, and up to 12 months when available.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: JET Enhanced Thrombectomy Intervention Registry - JETi Registry
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort Intervention/treatment
JETi Peripheral Thrombectomy System
Subjects who were treated with JETi Peripheral Thrombectomy System will be included.
Device: JETi Peripheral Thrombectomy System
The JETi Peripheral Thrombectomy System is comprised of the JETi Peripheral Catheter, JETi Pump Set, and JETi Peripheral Saline Drive Unit (SDU). The JETi Peripheral Thrombectomy System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Peripheral Catheter, while aspirating thrombotic material macerated by the saline stream




Primary Outcome Measures :
  1. Percentage reduction in patient clot removal grade for each JETi-treated target vessel [ Time Frame: From pre-JETi angiogram/venogram to post-JETi angiogram/venogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) ]

    Rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below:

    • Grade I: < 50% reduction
    • Grade II: 50-99% reduction
    • Grade III: 100% reduction

  2. Rate of JETi-related adverse events [ Time Frame: Up to 30 days post-index procedure ]
    Rate of JETi-related AEs such as (Amputation of treated limb, Bleeding - requiring transfusion, Blood loss - requiring transfusion etc.) will be assessed up to 30 days post-index procedure. Relationship to JETi will be investigator determined.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.
Criteria

Inclusion Criteria:

  1. Subject is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Peripheral 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370691


Contacts
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Contact: Vinuta Rau, PhD +1 408-845-0864 vinuta.rau@abbott.com
Contact: Stacy Scribner +1 651-756-5602 stacy.scribner@abbott.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Venkatesh Ramaiah, MD         
United States, Arkansas
Arkansas Heart Recruiting
Little Rock, Arkansas, United States, 72211
Principal Investigator: Vasili Lendel         
United States, California
PIH Good Samaritan Recruiting
Los Angeles, California, United States, 90017
Principal Investigator: Guy Mayeda         
Stanford University Hospital and Clinics Recruiting
Palo Alto, California, United States, 94305
Contact: Andrea Otte       anotte@stanford.edu   
Principal Investigator: William Kuo         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Mahmood Kabeil       mahmood.kabeil@cuanschutz.edu   
Principal Investigator: Donald Jacobs         
United States, Delaware
St Francis Hospital Withdrawn
Wilmington, Delaware, United States, 19805
United States, Indiana
St. Mary Medical Center Active, not recruiting
Hobart, Indiana, United States, 46342
United States, Iowa
Midwest Cardiovascular Research Foundation Active, not recruiting
Davenport, Iowa, United States, 52803
United States, Kansas
University of Kansas Medical Center Research Institute Withdrawn
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Soutchoast Hospital Recruiting
New Bedford, Massachusetts, United States, 02740
Contact: Richard Pin, MD         
Principal Investigator: Richard Pin, MD         
United States, Michigan
Henry Ford Detroit Recruiting
Detroit, Michigan, United States, 48202
Contact: Loay Kabbani, MD         
Principal Investigator: Loay Kabani, MD         
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Rosa Chu       roc2025@med.cornell.edu   
Principal Investigator: Brian DeRubertis         
Germany
University Hospital Aachen Recruiting
Aachen, Nordrhein Westfalen, Germany, 52074
Principal Investigator: Houman Jalaie         
Marien Hospital Herne Active, not recruiting
Herne, Nordrhein Westfalen, Germany, 44625
Klinikum Hochsauerland Recruiting
Arnsberg, Germany, 59759
Contact: Susanne Hochstein       s.hochstein@klinikum-hochsauerland.de   
Principal Investigator: Michael Lichtenberg         
Sankt Gertrauden Krankenhaus Recruiting
Berlin, Germany, 10713
Contact: Heike Bütow       heike.buetow@sankt-gertrauden.de   
Principal Investigator: Ralf Langhoff         
Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04370691    
Other Study ID Numbers: ABT-CIP-10433
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abbott Medical Devices:
ABT-CIP-10433
JETi Peripheral Thrombectomy System
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases