Terumo Aortic Global Endovascular Registry

Recruiting

• Conditions: Surgery; Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm

• Registration Number: NCT04246463
• Lead Sponsor: Vascutek Ltd.

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.

Study Timeline

• Study First Submitted: 2019-11-26
• Study Start: 2019-12-17
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2029-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aortic Related Mortality	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

Secondary Outcome Measures

Name	Time	Method
Technical Success	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
Composite Clinical Success	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%)

Trial Locations

Locations (44)

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-Étienne, France

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