Terumo Aortic Global Endovascular Registry

Surgery Clinical Trial

— TiGER  

Official title:

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246463
• Other study ID #: TiGER-001
• Status: Recruiting
• Start date: December 17, 2019
• Est. completion date: November 2030

Study information

• Verified date: June 2023
• Source: Vascutek Ltd.
• Contact: Michelle Durnan
• Phone: +441418125555
• Email: m.durnan[@]terumoaortic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2030
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Surgery
• Thoracic Aortic Aneurysm

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	Imeldaziekenhuis	Bonheiden
France	Hôpital Pneumologique et Cardiovasculaire Louis-Pradel	Bron
France	CHU St Etienne	Saint-Étienne
Germany	Klinikum Augsburg	Augsburg
Germany	Evangelisches Krankenhaus Hubertus	Berlin
Germany	Klinikum Chemnitz	Chemnitz
Germany	University Heart Center Freiburg	Freiburg
Germany	Aortic Center University Hospital	Göttingen
Germany	Bonifatius Hospital	Lingen
Germany	St. Franziskus Hospital	Münster
Germany	University Hospital Tübingen	Tübingen
Italy	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
Netherlands	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
Portugal	Centro Hospital Uni Lisboa Norte	Lisboa
Portugal	Hospital de Santa Marta	Lisboa
Portugal	CHU Sao Joao	Porto
Spain	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
Switzerland	Luzerner Kantonsspital	Lucerne
Switzerland	Civico, Ospedale Regionale	Lugano
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Oxford University Hospital	Oxford
United States	University of Michigan	Ann Arbor	Michigan
United States	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	Sentara Heart Hospital	Norfolk	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	Baylor, Scott & White Health (BSW Health)	Texas City	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Vascutek Ltd.	Bolton Medical

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Health Economics	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
Primary	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	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; 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
Secondary	Composite Clinical Success	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