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

Study Overview
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Brief Summary
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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
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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).

Official Title
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An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: TREO Stent-Graft System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREO Stent-Graft<br>Patients who receive a TREO Abdominal Stent-Graft System | Device: TREO Stent-Graft System<br>* The TREO® Stent-Graft is designed for use in the management of patients with AAAs and is composed of self-expanding nitinol stents sutured to polyester vascular graft fabric.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysm-related mortality |  | 30 days post-procedure | 
| Stroke (excluding transient ischemic attack) |  | 30 days post-procedure | 
| Myocardial infarction | Raised cardiac enzymes within 30 days of the procedure | 30 days post-procedure | 
| Renal failure | Renal failure requiring renal replacement therapy (excluding renal insufficiency) | 30 days post-procedure | 
| Respiratory failure | excluding chronic obstructive pulmonary disease or pulmonary complications) | 30 days post-procedure | 
| Paraplegia | (excluding paraparesis) | 30 days post-procedure | 
| Bowel ischemia | A restriction in blood supply to tissues in the bowels | 30 days post-procedure | 
| Treated aneurysm rupture |  | 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAE) at the follow-up time points | MAE includes any of the following : Aneurysm-related mortality, Stroke (excluding transient ischemic attack), Myocardial infarction, Renal failure requiring renal replacement therapy (excluding renal insufficiency), Respiratory failure (excluding chronic obstructive pulmonary disease or pulmonary complications), Paraplegia (excluding paraparesis), Bowel ischemia, Treated aneurysm rupture | 30 days post-procedure | 
| Limb Ischemia | Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation. | 30 days post-procedure | 
| Secondary procedures | Freedom from aneurysm-related secondary procedures through five years follow-up. A questionnaire will be conducted. Investigators are required to conduct a lesion and device assessment at each follow-up visit. All secondary procedures reported will be treated descriptively in terms of results. | 5 years | 
| Vascular access complications | Injuries to vessels as a result of the endovascular procedure. | Vascular access will be evaluated on day of index procedure (implant) | 
| Patient-reported quality of life (QOL) | Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument. | One year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Abdominal Aortic Aneurysms