Terumo Aortic Global Endovascular Registry (TiGER)

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: Surgery; Thoracic Aortic Aneurysm; Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Thoracic; Device: Abdominal; Device: Custom Device; Device: Illiac Artery

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

• Study Contact: Name: Michelle Durnan; Phone Number: +44 141 343 0195; Email: m.durnan@terumoaortic.com
• Study Contact Backup: Name: Sammy Jassal; Phone Number: +44 141 343 0195; Email: s.dhaliwal@terumoaortic.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imeldaziekenhuis
    • Contact: Wouter van den Eynde
  • Brussels, Belgium
    • Withdrawn
    • Clinques Uni. St Lucs
• France
  • Bron, France
    • Recruiting
    • Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
    • Contact: Antoine Millon, Prof
  • Saint-Etienne, 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 im Breisgau, Germany
    • Recruiting
    • University Heart Center Freiburg
    • Contact: Roman Gottardi, Dr
  • Göttingen, Germany
    • Withdrawn
    • Aortic Center University Hospital
  • Lingen, Germany
    • Recruiting
    • Bonifatius Hospital
    • Contact: Dr J Tesarek
  • Münster, Germany
    • Recruiting
    • St. Franziskus Hospital
    • Principal Investigator: Martin Austermann
  • 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
  • Modena, Italy
    • Not yet recruiting
    • Uni. di Modena
    • Principal Investigator: Roberto Silingardi, Prof
  • Siena, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Senese
    • Contact: Eugenio Neri, Prof
  • Turin, Italy
    • Recruiting
    • Maurizano Torino (turin)
    • Principal Investigator: A Gaggiano, Dr
  • Turin, Italy
    • Not yet recruiting
    • Turin Uni. Hospital
    • Principal Investigator: Fabio Verzini
• 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
    • Contact: Study Coordinator
    • Principal Investigator: Hans Dr Smeenk
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus University Medical Center
    • Principal Investigator: Hence Verhagen, Prof
  • Utrecht, Netherlands
    • Recruiting
    • Diakonessenhuis
    • Contact: Mattijs De Vries, Prof
• Portugal
  • Lisbon, Portugal
    • Recruiting
    • Hospital de Santa Marta
    • Principal Investigator: Emilla Ferrira, Dra
  • Lisbon, Portugal
    • Recruiting
    • Centro Hospital Uni Lisboa Norte
    • Principal Investigator: Pedro Amorim, DR
  • Porto, Portugal
    • Withdrawn
    • CHU Sao Joao
• Spain
  • Badalona, Spain
    • Recruiting
    • Hospital Universitari Germans
    • Principal Investigator: Secundi Lagostera, DR
  • Barcelona, Spain
    • Recruiting
    • Hospital Clínic 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
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Maani Hakimi
  • Lugano, Switzerland
    • Withdrawn
    • Civico, Ospedale Regionale
• United Kingdom
  • Derby, United Kingdom
    • Not yet recruiting
    • Royal Derby Hospital
    • Principal Investigator: Ganesh Dr Kuhan
  • 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
  • California
    • Long Beach, California, United States, 90806
      • Recruiting
      • Long Beach Memorial Medical Center
      • Principal Investigator: Ali Khoynezhad
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Principal Investigator: Rafael Malgor, MD
    • Colorado Springs, Colorado, United States, 80909
      • Recruiting
      • UC Health Memorial Hospital Center
      • Principal Investigator: Melham Sharafuddin
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Principal Investigator: Prashanth Vallabhajoysyula
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center
      • Principal Investigator: Christian Shults
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Eric Jeng
  • 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
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
      • Principal Investigator: Joseph Lombardi
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Wilson Szeto
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh
      • Principal Investigator: Ibrahim Sulton
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Ascension Texas Cardiovascular / UT Dell Medical School
      • Principal Investigator: Joshua Grimm
    • 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
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virgina
      • Principal Investigator: Bezhad Farivar
    • Norfolk, Virginia, United States, 22042
      • Recruiting
      • Sentara Heart Hospital
      • Principal Investigator: Jean Panneton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

US ONLY:TEVAR patients treated with a RelayPro Device. Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU, transection or IMH. OUS: TEVAR- Patients requiring urgent/elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU or IMH. Abdominal - EVAR Patients requiring urgent/elective endovascular treatment of infrarenal abdominal aortic aneurysm. Custom Device - FEVAR Patients with a documented thoracic/abdominal pathology suitable for elective treatment using a custom Terumo endovascular device. Ascending/Type A Dissections. Other- Isolated Iliac Artery Aneurysm .Patients requiring urgent or elective endovascular treatment of isolated Iliac Artery Aneurysms. As new indications/devices are approved those may also be captured.

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) 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

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	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	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 (or entry tear in the case of dissection);Absence of unplanned coverage or aortic branch vessels; Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, 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 IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound).	Day 0
Composite Clinical Success	defined as the absence of: Target lesion related mortality Type Ia, Ib, IIIa and IIIb endoleak Graft infection Stent patency <50% Target lesion aortic rupture Conversion to open repair Arrest of the original pathological process (e.g., total aortic diameter expansion >5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)	1 year
Additional Endpoints	All-cause mortality Safety (MAEs, all related adverse events) Target lesion reintervention, all secondary interventions Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcome measure	• 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	The following health economic will also be summarized: Total procedure time (mins) Fluoroscopy time (mins) Blood loss (ml) Blood transfusion required (ml) Time in ICU (hours/mins) Time to hospital discharge (days) Total Procedure time (mins) Total anesthesia time (hours) Total Procedure to discharge time (hours/days)	From Procedure to 1 Year
Health Economics	The following health economic will also be summarized: Arterial access route and type (Percutaneous or Cut down)	Day 0
Health Economics	The following health economic will also be summarized: Volume of contrast media used Volume of Blood loss Volume of Blood transfusion required	Day 0
Health Economics	The following health economic will also be summarized: Type of Image fusion technology used Type of Magnet system used	Day 0

Collaborators and Investigators

• Sponsor: Vascutek Ltd.
• Collaborators: Bolton Medical

Study record dates

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): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• 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