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NCT04246463Recruiting

Terumo Aortic Global Endovascular Registry

Vascutek Ltd.

Start Date

12/17/2019

Completion Date

11/1/2030

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.

Detailed Description

Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Thoracic

DEVICE

Abdominal

DEVICE

Custom Device

DEVICE

Illiac Artery

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Conditions

Abdominal Aortic AneurysmThoracic Aortic AneurysmSurgery

Locations

Long Beach Memorial Medical Center

Long Beach, California 90806

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

UC Health Memorial Hospital Center

Colorado Springs, Colorado 80909

United States

Yale University

New Haven, Connecticut 06520

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

University of Florida

Gainesville, Florida 32610

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

Cooper University Hospital

Camden, New Jersey 08103

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15232

United States

Ascension Texas Cardiovascular / UT Dell Medical School

Austin, Texas 78705

United States

Baylor, Scott & White Health (BSW Health)

Texas City, Texas 75093

United States

University of Utah

Salt Lake City, Utah 84132

United States

University of Virgina

Charlottesville, Virginia 22908

United States

Sentara Heart Hospital

Norfolk, Virginia 22042

United States

Imeldaziekenhuis

Bonheiden,

Belgium

Clinques Uni. St Lucs

Brussels,

Belgium

Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

Bron,

France

CHU St Etienne

Saint-Etienne,

France

Klinikum Augsburg

Augsburg,

Germany

Evangelisches Krankenhaus Hubertus

Berlin,

Germany

Klinikum Chemnitz

Chemnitz,

Germany

University Heart Center Freiburg

Freiburg im Breisgau,

Germany

Aortic Center University Hospital

Göttingen,

Germany

Bonifatius Hospital

Lingen,

Germany

St. Franziskus Hospital

Münster,

Germany

University Hospital Tübingen

Tübingen,

Germany

Policlinico Consorziale di Bari

Bari,

Italy

Compensorio Sanitario Bolzano

Bolzano,

Italy

Cagliari-Ospedale Brotzu

Cagliari,

Italy

Firenze Ospedale Careggi

Careggi,

Italy

Azienda Ospedaliera di Catania

Catania,

Italy

Uni. di Modena

Modena,

Italy

Azienda Ospedaliera Universitaria Senese

Siena,

Italy

Maurizano Torino (turin)

Turin,

Italy

Turin Uni. Hospital

Turin,

Italy

Vumc Amsterdam

Amsterdam,

Netherlands

Rijnstate Arnham

Arnhem,

Netherlands

Medisch Spectrum Twente

Enschede,

Netherlands

UMC Gronigen

Groningen,

Netherlands

St. Antonius Ziekenhuis

Nieuwegein, 3430

Netherlands

Erasmus University Medical Center

Rotterdam,

Netherlands

Diakonessenhuis

Utrecht,

Netherlands

Centro Hospital Uni Lisboa Norte

Lisbon,

Portugal

Hospital de Santa Marta

Lisbon,

Portugal

CHU Sao Joao

Porto,

Portugal

Hospital Universitari Germans

Badalona,

Spain

Hospital Clinic i Provincial de Barcelona

Barcelona,

Spain

Hospital Universitari Valle Hebrón de Barcelona

Barcelona,

Spain

Hospital Universitario Central de Asturias, Oviedo

Oviedo,

Spain

Luzerner Kantonsspital

Lucerne,

Switzerland

Civico, Ospedale Regionale

Lugano,

Switzerland

Royal Derby Hospital

Derby,

United Kingdom

Hull Royal Infirmary

Hull,

United Kingdom

Manchester Royal Infirmary

Manchester,

United Kingdom

Oxford University Hospital

Oxford,

United Kingdom