Clinical trial NCT04246463: Terumo Aortic Global Endovascular Registry
Official title: A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Thoracic Aortic Aneurysm
Surgery
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bolton Medical
First posted: 2020-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Aortic Related Mortality
timeFrame: 30 days post implant
Secondary outcomes:
measure: Technical Success
timeFrame: Day 0
measure: Composite Clinical Success
timeFrame: 1 year
Other outcomes:
measure: Patient Outcome measure
timeFrame: 1 Year
measure: Health Economics
timeFrame: Day 0
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Chicago
country: United States
facility: Loyola University of Chicago (Loyola)
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St. Vincent Heart Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Texas City
country: United States
facility: Baylor, Scott & White Health (BSW Health)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Bron
country: France
facility: Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
city: Saint-Étienne
country: France
facility: CHU St Etienne
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Hubertus
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Freiburg
country: Germany
facility: University Heart Center Freiburg
city: Göttingen
country: Germany
facility: Aortic Center University Hospital
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Bari
country: Italy
facility: Policlinico Consorziale di Bari
city: Bolzano
country: Italy
facility: Compensorio Sanitario Bolzano
city: Cagliari
country: Italy
facility: Cagliari-Ospedale Brotzu
city: Careggi
country: Italy
facility: Firenze Ospedale Careggi
city: Catania
country: Italy
facility: Azienda Ospedaliera di Catania
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Turin
country: Italy
facility: Maurizano Torino (turin)
city: Amsterdam
country: Netherlands
facility: Vumc Amsterdam
city: Arnhem
country: Netherlands
facility: Rijnstate Arnham
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: UMC Gronigen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Lisboa
country: Portugal
facility: Centro Hospital Uni Lisboa Norte
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Porto
country: Portugal
facility: CHU Sao Joao
city: Badalona
country: Spain
facility: Hospital Universitari Germans
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Valle Hebrón de Barcelona
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias, Oviedo
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
city: Lugano
country: Switzerland
facility: Civico, Ospedale Regionale
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: Oxford University Hospital
Study officials:
References: