Terumo Aortic Global Endovascular Registry

Recruiting

• Conditions: Surgery; Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm
• Interventions: Device: Abdominal; Device: Thoracic; Device: Illiac Artery; Device: Custom Device

• Registration Number: NCT04246463
• Lead Sponsor: Vascutek Ltd.

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.

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.

Study Timeline

• Study First Submitted: 2019-11-26
• Study Start: 2019-12-17
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2029-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

  • 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
  • Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal - EVAR	Abdominal	-
Thoracic - TEVAR	Thoracic	-
Other indications	Illiac Artery	Isolated Iliac Artery Aneurysm (IIAA)
Custom Device	Custom Device	-

Primary Outcome Measures

Name	Time	Method
Aortic Related Mortality	30 days post implant	Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion

Secondary Outcome Measures

Name	Time	Method
Technical Success	Day 0	defined as: Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery) Deployment of the endovascular stent graft in the planned location with coverage of the target lesion; Patency of the endovascular stent graft, absence of device deformations (e.g. kinks, stent eversion, mal-deployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stent graft, and; Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal) Absence of Type Ia, Type Ib, Type IIIa and Type IIIb endoleak
Composite Clinical Success	1 year	defined as the absence of: Target lesion related mortality Target lesion aortic rupture Target lesion reintervention Occurrence of Endoleaks (Type Ia, Ib, III and IV) Loss of stent patency (\>50%) Clinically significant stent graft migration (≥10mm) Stent fracture Stroke (modified Rankin Scale score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline) New onset renal failure requiring dialysis Graft infection or thrombosis Where aneurysm is present Aneurysm expansion (diameter ≥5 mm, or volume ≥5%)

Trial Locations

Locations (44)

Loyola University of Chicago (Loyola); 🇺🇸 Chicago, Illinois, United States

Ascension St. Vincent Heart Center; 🇺🇸 Indianapolis, Indiana, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Klinikum Chemnitz; 🇩🇪 Chemnitz, Germany

Compensorio Sanitario Bolzano; 🇮🇹 Bolzano, Italy

CHU St Etienne; 🇫🇷 Saint-Étienne, France

UMC Gronigen; 🇳🇱 Groningen, Netherlands

Policlinico Consorziale di Bari; 🇮🇹 Bari, Italy

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Hospital de Santa Marta; 🇵🇹 Lisboa, Portugal

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Firenze Ospedale Careggi; 🇮🇹 Careggi, Italy

Vumc Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Hospital Tübingen; 🇩🇪 Tübingen, Germany

Azienda Ospedaliera di Catania; 🇮🇹 Catania, Italy

Luzerner Kantonsspital; 🇨🇭 Lucerne, Switzerland

CHU Sao Joao; 🇵🇹 Porto, Portugal

Baylor, Scott & White Health (BSW Health); 🇺🇸 Texas City, Texas, United States

Sentara Heart Hospital; 🇺🇸 Norfolk, Virginia, United States

Hôpital Pneumologique et Cardiovasculaire Louis-Pradel; 🇫🇷 Bron, France

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

University Heart Center Freiburg; 🇩🇪 Freiburg, Germany

Evangelisches Krankenhaus Hubertus; 🇩🇪 Berlin, Germany

Aortic Center University Hospital; 🇩🇪 Göttingen, Germany

St. Franziskus Hospital; 🇩🇪 Münster, Germany

Bonifatius Hospital; 🇩🇪 Lingen, Germany

Cagliari-Ospedale Brotzu; 🇮🇹 Cagliari, Italy

Maurizano Torino (turin); 🇮🇹 Turin, Italy

Rijnstate Arnham; 🇳🇱 Arnhem, Netherlands

Centro Hospital Uni Lisboa Norte; 🇵🇹 Lisboa, Portugal

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari Valle Hebrón de Barcelona; 🇪🇸 Barcelona, Spain

Civico, Ospedale Regionale; 🇨🇭 Lugano, Switzerland

Hospital Universitari Germans; 🇪🇸 Badalona, Spain

Hospital Universitario Central de Asturias, Oviedo; 🇪🇸 Oviedo, Spain

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Oxford University Hospital; 🇬🇧 Oxford, United Kingdom