Aortic Aneurysm, Abdominal
Conditions
Keywords
AAA, Abdominal Aortic Aneurysms
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).
Interventions
DEVICETREO Stent-Graft System
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.
Sponsors
Bolton Medical Espana SLU
Bolton Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treated aneurysm rupture | 30 days post-procedure | — |
| Myocardial infarction | 30 days post-procedure | Raised cardiac enzymes within 30 days of the procedure |
| Renal failure | 30 days post-procedure | Renal failure requiring renal replacement therapy (excluding renal insufficiency) |
| Respiratory failure | 30 days post-procedure | excluding chronic obstructive pulmonary disease or pulmonary complications) |
| Paraplegia | 30 days post-procedure | (excluding paraparesis) |
| Bowel ischemia | 30 days post-procedure | A restriction in blood supply to tissues in the bowels |
| Aneurysm-related mortality | 30 days post-procedure | — |
| Stroke (excluding transient ischemic attack) | 30 days post-procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limb Ischemia | 30 days post-procedure | Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation. |
| Secondary procedures | 5 years | 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. |
| Vascular access complications | Vascular access will be evaluated on day of index procedure (implant) | Injuries to vessels as a result of the endovascular procedure. |
| Patient-reported quality of life (QOL) | One year follow-up | Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument. |
| Major Adverse Events (MAE) at the follow-up time points | 30 days post-procedure | 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 |
Countries
Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed