RECRUITING

Terumo Aortic Global Endovascular Registry

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Conditions

Abdominal Aortic AneurysmThoracic Aortic AneurysmSurgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Official Title

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

Quick Facts

Study Start:2019-12-17
Study Completion:2030-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04246463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Minimum age as per local regulations
  2. * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
  3. * Ability to provide informed consent
  4. * Willingness to comply with the registry protocol
  5. * Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.
  1. * • Patient is unable or unwilling to comply with the study follow-up regime.
  2. * Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure
  3. * Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)

Contacts and Locations

Study Contact

Michelle Durnan
CONTACT
+441418125555
m.durnan@terumoaortic.com
Sammy Dhaliwal
CONTACT
+441418125555
s.dhaliwal@terumoaortic.com

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Loyola University of Chicago (Loyola)
Chicago, Illinois, 60153
United States
Ascension St. Vincent Heart Center
Indianapolis, Indiana, 46260
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Baylor, Scott & White Health (BSW Health)
Texas City, Texas, 75093
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Sentara Heart Hospital
Norfolk, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: Vascutek Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-17
Study Completion Date2030-11

Study Record Updates

Study Start Date2019-12-17
Study Completion Date2030-11

Terms related to this study

Additional Relevant MeSH Terms

  • Abdominal Aortic Aneurysm
  • Thoracic Aortic Aneurysm
  • Surgery