Abdominal Aortic Aneurysm
Conditions
Interventions
None
Sponsors
Haga Vascular Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years Candidacy for endovascular repair of the aneurysm of the aorta (AAA) AAA with the following criteria =55 mm in diameter or growth =5mm during 6 months Or saccular AAA Elective (Non-ruptured) Femoral access to fit the delivery system
Exclusion criteria
Exclusion criteria: Dissection of the infrarenal aorta Ruptured aorta Infrarenal aorta angulation = 60 ° Aortic bifurcation = 18mm in diameter Aortic length ( from lowest renal artery to aortic bifurcation) < 8.7 cm Circumferential thrombosis and/or calcification of infrarenal neck GFR < 20 High probability of non-adherence to the study Participation in concurrent aorto-iliac trial Incapability of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trial is designed with primary efficacy and primary safety endpoints. The primary efficacy endpoint of the study is technical success defined by stentgraft deployment at the desired location without type I, III or IV endoleak and successful percutaneous access and closure at the end of the procedure. The primary safety endpoint of the study is absence of type I, III or IV endoleak or device, and absence of access or procedure related major adverse events at one month. Major adverse events are defined as any death, myocardial infarction, stroke, dialysis requiring renal failure or surgical conversion at the aneurysm or access sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Numbers of percutaneous closure device failure. Numbers of surgical conversion at the access site. Numbers of patients with local anesthesia, sedation and general anesthesia required for the implantation of the stentgraft. Peri-procedural blood loss. Number of ICU days. Number of days hospital stay. At one month and 12 months: Surgical conversion at the aneurysm site Surgical conversion at the access site Pseudoaneurysms at the access site. Distal emboli Graft thrombosis Graft fracture Graft migration of 10 mm or more Endoleaks type I, III & IV Endoleaks type II Secondary procedures to correct endoleaks Secondary procedures to correct kinking or thrombosis of graft Major amputation All cause mortality Aneurysm rupture related mortality Graft related mortality Myocardial infarction Bowel ischemia Stroke Renal ischemia causing dialysis | — |
Contacts
Public ContactJan J Wever
Stichting Haga Vascular Research
Outcome results
None listed