Recruiting

Observational StudyTerumo Aortic Global Endovascular Registry

Sponsor:

Vascutek Ltd.

Code:

NCT04246463

Conditions

Abdominal Aortic Aneurysm

Thoracic Aortic Aneurysm

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thoracic

Abdominal

Custom Device

Illiac Artery

Study Details

Brief summary:

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

Study ID

NCT04246463

Start date

Dec 17, 2019

Status verified date

Jul, 2025

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR).

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.

Exclusion Criteria:

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Thoracic - TEVAR

Abdominal - EVAR

Custom Device

Other indications

Isolated Iliac Artery Aneurysm (IIAA)

Interventions

Thoracic

Implant of a Relay stent graft system

Abdominal

Implant with an Anaconda or Treo Stent graft system

Custom Device

Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device

Illiac Artery

Implant with an Anaconda Iliac leg only

Primary outcome measure

Aortic Related Mortality [ Time Frame: 30 days post implant ]

Central Contacts and Locations

Central contacts

Michelle Durnan

+44 141 343 0195 m.durnan@terumoaortic.com

Sammy Jassal

+44 141 343 0195 s.dhaliwal@terumoaortic.com

Locations

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Principal Investigator:

Ali Khoynezhad

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Rafael Malgor, MD

UC Health Memorial Hospital Center

Recruiting

Colorado Springs, Colorado, United States, 80909

Principal Investigator:

Melham Sharafuddin

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Prashanth Vallabhajoysyula

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Christian Shults

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator:

Eric Jeng

Loyola University of Chicago (Loyola)

Recruiting

Chicago, Illinois, United States, 60153

Principal Investigator:

Carlos Bechara, MD

Ascension St. Vincent Heart Center

Recruiting

Indianapolis, Indiana, United States, 46260

Principal Investigator:

Sina L Moainie, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Shinichi Fukuhara, MD

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Principal Investigator:

Joseph Lombardi

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Wilson Szeto

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Ibrahim Sulton

Ascension Texas Cardiovascular / UT Dell Medical School

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Joshua Grimm

Baylor, Scott & White Health (BSW Health)

Recruiting

Texas City, Texas, United States, 75093

Principal Investigator:

Dennis Gable, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator:

Jason Glozbach

University of Virgina

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Bezhad Farivar

Sentara Heart Hospital

Recruiting

Norfolk, Virginia, United States, 22042

Principal Investigator:

Jean Panneton, MD

More Information

Sponsor

Vascutek Ltd.

Last update posted

Mar 13, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vascutek Ltd. on 2026-03-13.