Abdominal Aortic Aneurysm (AAA) abnormal dilatation of the abdominal aorta
Conditions
Interventions
Implantation of a Treovance Stent-Graft with Navitel Delivery System
Sponsors
Bolton Medical Espana S.L.U.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a.) Subject must be between the ages of 18 and 85. b.) Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure. c.) Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or ii. has increased in diameter by 0.5 cm in the last 6 months d.) Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 17 mm - 32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 16 mm-30 mm e.) Subject*s infrarenal landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices f.) Subject must have lowest renal artery at least 9 cm from the aortic bifurcation g.) Subject must have a distal iliac landing neck with i. an inside diameter of 7 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of >13 mm - 20 mm and a length of at least 15 mm h.) Subject*s distal iliac landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified for the corresponding devices in the IFU i.) Subject must have a total treatment length of at least 13 cm j.) Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits. k.) Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel Delivery System which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject*s anatomy is suitable for creation of an iliac conduit. l.) Subject or Legally Authorized Representative (LAR) must agree to sign Informed Consent Form
Exclusion criteria
Exclusion criteria: Subjects may not enroll into the study if any of the following apply: a.) Subject is pregnant or lactating b.) Subject has a dissection, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician) c.) Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery d.) Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging e.) Subject has a lesion that cannot be crossed by a guide wire f.) Proximal neck cannot increase by more than 10% over 15 mm; i.e., no trapezoidal necks g.) Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction 2.5 mg/dL) q.) Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.) r.) Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure. s.) Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion. t.) Subject has had a prior AAA repair (endovascular or surgical) u.) Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester v.) Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., CABG, organ transplantation, renal stenting, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome - Safety Safety will be assessed by measurement of mortality and major morbidity. Each of the events identified below will be evaluated compositely as well as individually. The evaluations will be made at all follow-up intervals. a) Death (all causes where subject death is the result of a serious and device- or procedure-related adverse effect). Unrelated and accidental deaths, for example a subject death due to injuries from a car accident, would not be included in this evaluation. b) Stroke (excludes transient ischemic attack) c) Myocardial Infarction d) Renal Failure requiring renal replacement therapy (excludes renal insufficiency) e) Respiratory Failure, defined as ventilator-dependent (excludes chronic obstructive pulmonary disease or pulmonary complications) f) Paraparesis / Paraplegia g) Bowel ischemia h) Treated aneurysm rupture | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints - Endovascular Parameters The following endovascular measures will be assessed for preliminary performance at the follow-up intervals. a) Delivery/Deployment: vessel access was achieved and the physician was able to insert the delivery catheter and deliver it to the treatment site and deploy the device b) Stent-Graft Migration: longitudinal movement of all or part of the stent-graft greater than 10 mm relative to its placement as measured by imaging studies at the 1-month follow-up versus the 6-month and 12-month follow-ups c) Stent-Graft Patency: a measure of blood flow through the vessel treated and the stent-graft d) Stent-Graft Integrity: an assessment of stent-graft fractures, or kinking or twisting leading to occlusion or ischemiae) Endoleak: persistence of flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft f) Aneurysm Sac Size Changes: a change in the diameter (5 mm change) of the lesion relative to the measurement at 1 month versus 6-month and 12-month follow-up visit measurements g) Limb Ischemia: resulting in limb loss h) Vascular Access Complications: injuries to vessels as a result of an endovascular procedure. | — |
Countries
Netherlands
Outcome results
None listed