An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 174
- Locations
- 16
- Primary Endpoint
- Stroke (excluding transient ischemic attack)
Study Overview
Brief Summary
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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TREO Stent-Graft
Patients who receive a TREO Abdominal Stent-Graft System
Intervention: TREO Stent-Graft System (Device)
Outcomes
Primary Outcomes
Stroke (excluding transient ischemic attack)
Time Frame: 30 days post-procedure
Respiratory failure
Time Frame: 30 days post-procedure
excluding chronic obstructive pulmonary disease or pulmonary complications)
Bowel ischemia
Time Frame: 30 days post-procedure
A restriction in blood supply to tissues in the bowels
Aneurysm-related mortality
Time Frame: 30 days post-procedure
Renal failure
Time Frame: 30 days post-procedure
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
Myocardial infarction
Time Frame: 30 days post-procedure
Raised cardiac enzymes within 30 days of the procedure
Paraplegia
Time Frame: 30 days post-procedure
(excluding paraparesis)
Treated aneurysm rupture
Time Frame: 30 days post-procedure
Secondary Outcomes
- Major Adverse Events (MAE) at the follow-up time points(30 days post-procedure)
- Limb Ischemia(30 days post-procedure)
- Vascular access complications(Vascular access will be evaluated on day of index procedure (implant))
- Secondary procedures(5 years)
- Patient-reported quality of life (QOL)(One year follow-up)