Percutaneous Closure Device Controlled Incraft Stentgraft Implantation Registry

Recruiting

Conditions: Abdominal Aortic Aneurysm

Registration Number: NL-OMON24291

Lead Sponsor: Haga Vascular Research Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The trial is designed with primary efficacy and primary safety endpoints. <br>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.<br>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. <br>Major adverse events are defined as any death, myocardial infarction, stroke, dialysis requiring renal failure or surgical conversion at the aneurysm or access sites. <br>

Secondary Outcome Measures

Name	Time	Method
umbers of percutaneous closure device failure.<br>Numbers of surgical conversion at the access site.<br>Numbers of patients with local anesthesia, sedation and general anesthesia required for the implantation of the stentgraft.<br>Peri-procedural blood loss.<br><br>Number of ICU days.<br>Number of days hospital stay.<br><br>At one month and 12 months:<br>Surgical conversion at the aneurysm site<br>Surgical conversion at the access site<br>Pseudoaneurysms at the access site.<br>Distal emboli<br>Graft thrombosis<br>Graft fracture<br>Graft migration of 10 mm or more<br>Endoleaks type I, III & IV<br>Endoleaks type II<br>Secondary procedures to correct endoleaks<br>Secondary procedures to correct kinking or thrombosis of graft<br>Major amputation<br>All cause mortality<br>Aneurysm rupture related mortality<br>Graft related mortality<br>Myocardial infarction<br>Bowel ischemia<br>Stroke<br>Renal ischemia causing dialysis<br>