An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Bolton Medical

Status: Terminated

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: TREO Stent-Graft System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03187522

IP-0020-16

Details and patient eligibility

About

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644.

The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

Full description

This is a prospective, multicenter, post-market clinical follow-up, non-randomized registry of the TREO Stent-Graft. Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac (AUI) device can be included into the registry. Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1, 2, 3, 4, and 5-year post-implantation.

The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms (AAA).

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Signed informed consent
• Willingness to comply with study follow-up
• Indication for elective endovascular repair
• Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to include any auxiliary device components

Exclusion criteria

• Intolerance to contrast media
• Emergency procedure
• Chimneys or fenestrated device procedures
• Connective tissue disease (e.g., Marfan's syndrome)
• High probability of non-adherence to follow-up requirements
• Current participation in a concurrent trial that may confound study results
• Female of childbearing potential in whom pregnancy cannot be excluded
• Previous endovascular or surgical AAA repair

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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174 participants in 1 patient group

TREO Stent-Graft

Experimental group

Description:

Patients who receive a TREO Abdominal Stent-Graft System

Treatment:

Device: TREO Stent-Graft System