Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2019-12-17
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Thoracic - TEVAR
Thoracic
Implant of a Relay stent graft system
Abdominal - EVAR
Abdominal
Implant with an Anaconda or Treo Stent graft system
Custom 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)
Illiac Artery
Implant with an Anaconda Iliac leg only
Interventions
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Thoracic
Implant of a Relay stent graft system
Abdominal
Implant with an Anaconda or Treo Stent graft system
Custom Device
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Illiac Artery
Implant with an Anaconda Iliac leg only
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Bolton Medical
INDUSTRY
Vascutek Ltd.
INDUSTRY
Responsible Party
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Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Loyola University of Chicago (Loyola)
Chicago, Illinois, United States
Ascension St. Vincent Heart Center
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Baylor, Scott & White Health (BSW Health)
Texas City, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
Imeldaziekenhuis
Bonheiden, , 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
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Maurizano Torino (turin)
Turin, , Italy
Vumc Amsterdam
Amsterdam, , Netherlands
Rijnstate Arnham
Arnhem, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
UMC Gronigen
Groningen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , 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
Hull Royal Infirmary
Hull, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Oxford University Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Wouter van den Eynde
Role: primary
Antoine Millon, Prof
Role: primary
Alexander Hyhlik-Duerr, Prof Dr Med
Role: primary
Ernst Weigang, Prof.Dr.Med.
Role: primary
Sven Seifert
Role: primary
Bartosz Rylski, Dr
Role: primary
Dr J Tesarek
Role: primary
Giovanni Torsello, Prof
Role: primary
Mario Lescan, Dr
Role: primary
Sammy Jassal
Role: primary
Sammy Jassal
Role: primary
Dominic Benevento, Dr
Role: primary
A.w.J Hoksbergen
Role: primary
M.M.P.J Reihnen
Role: primary
R.H Geelkerken
Role: primary
Clark Zeebregts
Role: primary
Study Coordinator
Role: primary
Mattijs De Vries, Prof
Role: primary
V Riambau
Role: primary
Maani Hakimi
Role: primary
Other Identifiers
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TiGER-001
Identifier Type: -
Identifier Source: org_study_id
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