Terumo Aortic Global Endovascular Registry

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.

Conditions

Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery

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Study Overview

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Study Details

Study overview

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.

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

Terumo Aortic Global Endovascular Registry

Condition
Abdominal Aortic Aneurysm
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Chicago

Loyola University of Chicago (Loyola), Chicago, Illinois, United States, 60153

Indianapolis

Ascension St. Vincent Heart Center, Indianapolis, Indiana, United States, 46260

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Texas City

Baylor, Scott & White Health (BSW Health), Texas City, Texas, United States, 75093

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

Norfolk

Sentara Heart Hospital, Norfolk, Virginia, United States, 22042

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • Minimum age as per local regulations
  • * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
  • * Ability to provide informed consent
  • * Willingness to comply with the registry protocol
  • * 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.
  • * • Patient is unable or unwilling to comply with the study follow-up regime.
  • * 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
  • * Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vascutek Ltd.,

Study Record Dates

2030-11