Terumo Aortic Global Endovascular Registry (TiGER)

June 19, 2023 updated by: Vascutek Ltd.

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Recruiting
        • Imeldaziekenhuis
        • Contact:
          • Wouter van den Eynde
  • France
      • Bron, France
        • Recruiting
        • Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
        • Contact:
          • Antoine Millon, Prof
      • Saint-Étienne, France
        • Recruiting
        • CHU St Etienne
        • Principal Investigator:
          • Ben Ahmed, Dr
  • Germany
      • Augsburg, Germany
        • Recruiting
        • Klinikum Augsburg
        • Contact:
          • Alexander Hyhlik-Duerr, Prof Dr Med
      • Berlin, Germany
        • Recruiting
        • Evangelisches Krankenhaus Hubertus
        • Contact:
          • Ernst Weigang, Prof.Dr.Med.
      • Chemnitz, Germany
        • Recruiting
        • Klinikum Chemnitz
        • Contact:
          • Sven Seifert
      • Freiburg, Germany
        • Recruiting
        • University Heart Center Freiburg
        • Contact:
          • Bartosz Rylski, Dr
      • Göttingen, Germany
        • Withdrawn
        • Aortic Center University Hospital
      • Lingen, Germany
        • Recruiting
        • Bonifatius Hospital
        • Contact:
          • Dr J Tesarek
      • Münster, Germany
        • Recruiting
        • St. Franziskus Hospital
        • Contact:
          • Giovanni Torsello, Prof
      • Tübingen, Germany
        • Recruiting
        • University Hospital Tübingen
        • Contact:
          • Mario Lescan, Dr
  • Italy
      • Bari, Italy
        • Recruiting
        • Policlinico Consorziale di Bari
        • Contact:
          • Sammy Jassal
        • Principal Investigator:
          • Raffaele Pulli, Prof
      • Bolzano, Italy
        • Recruiting
        • Compensorio Sanitario Bolzano
        • Principal Investigator:
          • Reinhold Perkman, Dr
      • Cagliari, Italy
        • Recruiting
        • Cagliari-Ospedale Brotzu
        • Contact:
          • Sammy Jassal
        • Principal Investigator:
          • Stefano Camparini, Dr
      • Careggi, Italy
        • Recruiting
        • Firenze Ospedale Careggi
        • Principal Investigator:
          • Carlos Pratesi, DR
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera di Catania
        • Principal Investigator:
          • Pierfranceso Veroux, Dr
      • Siena, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Senese
        • Contact:
          • Dominic Benevento, Dr
      • Turin, Italy
        • Recruiting
        • Maurizano Torino (turin)
        • Principal Investigator:
          • A Gaggiano, Dr
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • VUMC Amsterdam
        • Contact:
          • A.w.J Hoksbergen
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Arnham
        • Contact:
          • M.M.P.J Reihnen
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:
          • R.H Geelkerken
      • Groningen, Netherlands
        • Recruiting
        • UMC Gronigen
        • Contact:
          • Clark Zeebregts
      • Nieuwegein, Netherlands, 3430
        • Not yet recruiting
        • St. Antonius Ziekenhuis
        • Principal Investigator:
          • Gus Lammeren
        • Contact:
          • Study Coordinator
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus University Medical Center
        • Principal Investigator:
          • Hence Verhagen, Prof
      • Utrecht, Netherlands
        • Recruiting
        • Diakonessenhuis
        • Contact:
          • Mattijs De Vries, Prof
  • Portugal
      • Lisboa, Portugal
        • Recruiting
        • Hospital De Santa Marta
        • Principal Investigator:
          • Emilla Ferrira, Dra
      • Lisboa, Portugal
        • Recruiting
        • Centro Hospital Uni Lisboa Norte
        • Principal Investigator:
          • Pedro Amorim, DR
      • Porto, Portugal
        • Not yet recruiting
        • CHU Sao Joao
        • Principal Investigator:
          • Jose Fernando Teixera, Dr
  • Spain
      • Badalona, Spain
        • Recruiting
        • Hospital Universitari Germans
        • Principal Investigator:
          • Secundi Lagostera, DR
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic I Provincial de Barcelona
        • Contact:
          • V Riambau
        • Principal Investigator:
          • Vincent Riambau, Prof
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Valle Hebrón de Barcelona
        • Principal Investigator:
          • Sergi Montoya Bellmunt, DR
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias, Oviedo
        • Principal Investigator:
          • Manuel Alonso, Dr
  • Switzerland
      • Lucerne, Switzerland
        • Not yet recruiting
        • Luzerner Kantonsspital
        • Contact:
          • Maani Hakimi
      • Lugano, Switzerland
        • Not yet recruiting
        • Civico, Ospedale Regionale
        • Principal Investigator:
          • Josa Van Den Berg, Dr
  • United Kingdom
      • Hull, United Kingdom
        • Recruiting
        • Hull Royal Infirmary
        • Principal Investigator:
          • Raghuram Lakshminarayan, DR
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Royal Infirmary
        • Principal Investigator:
          • David Murray, MR
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospital
        • Principal Investigator:
          • Raman Uberoi, DR
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Rafael Malgor, MD
    • Illinois
      • Chicago, Illinois, United States, 60153
        • Recruiting
        • Loyola University of Chicago (Loyola)
        • Principal Investigator:
          • Carlos Bechara, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent Heart Center
        • Principal Investigator:
          • Sina L Moainie, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Shinichi Fukuhara, MD
    • Texas
      • Texas City, Texas, United States, 75093
        • Recruiting
        • Baylor, Scott & White Health (BSW Health)
        • Principal Investigator:
          • Dennis Gable, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Jason Glozbach
    • Virginia
      • Norfolk, Virginia, United States, 22042
        • Recruiting
        • Sentara Heart Hospital
        • Principal Investigator:
          • Jean Panneton, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled under one of the following Modules Thoracic - TEVAR (Thoracic endovascular aneurysm/aortic repair) Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, penetrating aortic ulcer or intramural hematoma Abdominal - EVAR (Endovascular aneurysm/aortic repair) Patients requiring urgent or elective endovascular treatment of infrarenal abdominal aortic aneurysm.

Custom Device - FEVAR (Fenestrated endovascular aneurysm/aortic repair) Patients with a documented thoracic or abdominal pathology suitable for elective treatment using a custom-made Terumo Aortic endovascular device.

Other Isolated Iliac Artery Aneurysm (IIAA) Patients requiring urgent or elective endovascular treatment of isolated Iliac Artery Aneurysms (IAA)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thoracic - TEVAR
Device: Thoracic
Implant of a Relay stent graft system
Abdominal - EVAR
Device: Abdominal
Implant with an Anaconda or Treo Stent graft system
Custom Device
Device: Custom Device
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Other indications
Isolated Iliac Artery Aneurysm (IIAA)
Device: Illiac Artery
Implant with an Anaconda Iliac leg only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic Related Mortality
Time Frame: 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
30 days post implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: 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
Day 0
Composite Clinical Success
Time Frame: 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%)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Outcome measure
Time Frame: 1 Year
• Post-operative return to normal activities - employment, household activities, social life and hobbies (return to normal activities will be recorded at one year visit only)
1 Year
Health Economics
Time Frame: Day 0

The following health economic will also be summarized:

Total procedure timea Arterial access route and type Volume of contrast media used Fluoroscopy time Image fusion technology used Magnet system used Device re-positioned Blood loss Blood transfusion required Lower limb ischemia Time in ICU/MCUb Time to hospital dischargec Complications requiring reintervention/re-hospitalisation a Time from the first break of skin to final closure (i.e., skin to skin time, percutaneous, first access to last access closure).

b Time from the first administration of anesthesia to release from the ICU or post-anesthesia care unit providing ICU-level care. If the patient is not admitted to the ICU, this is defined as 0 hours.

c Time from initiation of the procedure to physical discharge from the hospital.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascutek Ltd.

Collaborators

Bolton Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TiGER-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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