I71.4
Conditions
Interventions
Group 1: Patients with infrarenal aortic aneurysms and the implantation of a TREO stent graft or a TREO AUI are asked to complete a quality of life questionnaire in the first year after implantation.
Sponsors
Terumo Aortic
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age >18 years Signed informed consent Willingness to comply with study follow up Indication for elective endovascular repair Planned implantation of single TREOdevice system or aorto uni-iliac (AUI) device to include any auxilliary device components
Exclusion criteria
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 physician's follow up requirements Current participation in a concurrent trials 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 |
|---|---|
| Safety will be assessed by measurement of mortality and major morbidity using a composite of major adverse events (MAEs, defined below) evaluated 30 days post-procedure: 1. Aneurysm-related mortality. 2. Stroke (excluding transient ischemic attack). 3. Myocardial infarction. 4. Renal failure requiring renal replacement therapy (excluding renal insufficiency). 5. Respiratory failure (excluding chronic obstructive pulmonary disease or pulmonary complications). 6. Paraplegia (excluding paraparesis). 7. Bowel ischemia. Treated aneurysm rupture. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be assessed for preliminary performance at all follow-up time points: Safety MAEs, device and procedure-related adverse events and complications at all follow-up intervals. Limb ischemia: rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation. Secondary procedures: freedom from aneurysm-related secondary procedures through five years follow-up. Vascular access complications: injuries to vessels as a result of the endovascular procedure. Unintentional coverage of renal arteries and/or hypogastric arteries; assessing the causes (device-related and/or procedure-related). All-cause mortality. Patient-reported quality of life (QOL) health outcomes using the EQ-5D standardized EuroQol instrument. Residual risk identification and assessment. Clinical results Primary Technical Success (successful introduction and deployment of the device in the absence of surgical conversion or mortality, type I or III endoleaks, or graft limb obstruction). Stent-Graft migration: longitudinal movement of all or part of the stent-graft greater than 10 mm relative to its placement or any migration leading to symptoms or requiring therapy as measured by imaging studies using 30-day follow-up measurement as baseline value. Stent-Graft patency: assessment of freedom from stent-graft or limb occlusion at 12-month follow-up. Stent-Graft integrity: an assessment of stent-graft fractures (including type IV endoleaks), or kinking or twisting leading to occlusion or ischemia. Endoleak: imaging assessment of endoleaks, subcategorized by device-related (types I and III, individually) and non-device related (type II). Aneurysm sac size changes: a > 5 mm change in the maximum sac diameter at 30-day follow-up compared with subsequent follow-up visit measurements. The following health economic parameters relating to the implant procedure will also be summarized: • Type of anesthesia. • Fluoroscopy | — |
Countries
Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Contacts
Public ContactGiovanni Torsello
Klinik für Gefäßchirurgie des St. Franziskus-Hospital
Outcome results
None listed