Terumo Aortic Global Endovascular Registry

Last updated: June 19, 2023
Sponsor: Vascutek Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Aneurysm

Heart Disease

Treatment

Custom Device

Thoracic

Illiac Artery

Clinical Study ID

NCT04246463
TiGER-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Minimum age as per local regulations
  • Indication for aortic endovascular repair with an approved or CE marked by aRegulatory body or custom-made Terumo Aortic Endovascular graft
  • Ability to provide informed consent o Emergent cases (typically younger patients with traumatic injuries) are notexcluded if there is IRB/EC agreement to allow consent after intervention (i.e.consent to study participation, not to treatment)
  • Willingness to comply with the registry protocol
  • Willingness to adhere to follow-up visits Note: Patients currently enrolled andactively participating within the TREO registry (IP-0020-16) can have their datamigrated from TREO to the TiGER registry where local EC approval has beenobtained and the patient has been reconsented to TiGER for longer follow-up.

Exclusion

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 orpsychological problems that in the opinion of the investigator preclude them fromreceiving treatment as well as the procedures and evaluations pre and postprocedure
  • Patient is eligible to be enrolled in or is currently actively participating inthe Terumo Aortic Global FACT clinical study (FACT-001)

Study Design

Total Participants: 1000
Treatment Group(s): 4
Primary Treatment: Custom Device
Phase:
Study Start date:
December 17, 2019
Estimated Completion Date:
November 30, 2030

Study 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.

Connect with a study center

  • Imeldaziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

    Bron,
    France

    Active - Recruiting

  • CHU St Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Klinikum Augsburg

    Augsburg,
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Hubertus

    Berlin,
    Germany

    Active - Recruiting

  • Klinikum Chemnitz

    Chemnitz,
    Germany

    Active - Recruiting

  • University Heart Center Freiburg

    Freiburg,
    Germany

    Active - Recruiting

  • Aortic Center University Hospital

    Göttingen,
    Germany

    Site Not Available

  • Bonifatius Hospital

    Lingen,
    Germany

    Active - Recruiting

  • St. Franziskus Hospital

    Münster,
    Germany

    Active - Recruiting

  • University Hospital Tübingen

    Tübingen,
    Germany

    Active - Recruiting

  • Policlinico Consorziale di Bari

    Bari,
    Italy

    Active - Recruiting

  • Compensorio Sanitario Bolzano

    Bolzano,
    Italy

    Active - Recruiting

  • Cagliari-Ospedale Brotzu

    Cagliari,
    Italy

    Active - Recruiting

  • Firenze Ospedale Careggi

    Careggi,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Catania

    Catania,
    Italy

    Active - Recruiting

  • Ospedale San Giovanni

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Senese

    Siena,
    Italy

    Active - Recruiting

  • Maurizano Torino (turin)

    Turin,
    Italy

    Active - Recruiting

  • Vumc Amsterdam

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Rijnstate Arnham

    Arnhem,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • UMC Gronigen

    Groningen,
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein, 3430
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Diakonessenhuis

    Utrecht,
    Netherlands

    Active - Recruiting

  • Centro Hospital Uni Lisboa Norte

    Lisboa,
    Portugal

    Active - Recruiting

  • Hospital de Santa Marta

    Lisboa,
    Portugal

    Active - Recruiting

  • CHU Sao Joao

    Porto,
    Portugal

    Site Not Available

  • Hospital Universitari Germans

    Badalona,
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari Valle Hebrón de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias, Oviedo

    Oviedo,
    Spain

    Active - Recruiting

  • Luzerner Kantonsspital

    Lucerne,
    Switzerland

    Site Not Available

  • Civico, Ospedale Regionale

    Lugano,
    Switzerland

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull,
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospital

    Oxford,
    United Kingdom

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Loyola University of Chicago (Loyola)

    Chicago, Illinois 60153
    United States

    Active - Recruiting

  • Ascension St. Vincent Heart Center

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Baylor, Scott & White Health (BSW Health)

    Texas City, Texas 75093
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Sentara Heart Hospital

    Norfolk, Virginia 22042
    United States

    Active - Recruiting

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