Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Iliac Aneurysm
- Sponsor
- JOTEC GmbH
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- Clinical success
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms.
Objectives of this post-market registry are:
Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unilateral or bilateral aorto-iliac or iliac aneurysm
- •Suitable for endovascular repair
- •Patient must be compliant with life- long follow-up investigations
- •\>18 years old
- •lliac/femoral access vessel morphology compatible with the implantation procedure and the 18Fr (6mm OD) delivery system
- •Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥ 20mm
- •Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm
- •Non-aneurysmal external iliac artery segment distal to the aneurysm ≥15mm
- •Diameter of the external iliac artery in the distal landing area: 8mm to 13mm
- •Non-aneurysmal internal iliac artery segment distal to the aneurysm ≥15mm
Exclusion Criteria
- •Patients who do not meet the instructions for use
- •Patients with one of the contraindications as indicated in the instructions for use
- •Patients with a stenotic internal iliac ostium of \< 4mm in Diameter
- •Patients with severe internal iliac atherosclerosis
- •Patients that do not have a suitable landing area in the main stem of the IIA (maximum diameter in landing area \<12mm)
- •Patients with pseudoaneurysms
- •Patients with symptomatic and ruptured iliac aneurysms
- •Patients pretreated with a AAA stent graft or a bifurcated vascular graft
- •Patient with thrombocytopenia
- •Patient with an estimated glomerular filtration rate \< 30 ml/min/1,73m2 immediately before the Intervention
Outcomes
Primary Outcomes
Clinical success
Time Frame: 30 days follow-up
Clinical success related to the E-liac Stent Graft combines the following criteria (adapted from Chaikof 2002): * Clinical success should be reported on an intent-to-treat Basis * requires successful deployment of the E-liac Stent Graft at the intended location without * Death as a result of iliac aneurysm-related treatment * Type I or III endoleak * E-liac Stent Graft infection * E-liac Stent Graft thrombosis (including internal iliac artery thrombosis) * Aneurysm growth \>3mm in maximum diameter for common iliac aneurysm and \>5mm in maximum diameter for aortic aneurysm at 12, 24, and 36 months follow-up * Common iliac aneurysm rupture * Conversion to open repair * Failure of E-liac Stent Graft integrity