Iliac Aneurysm
Conditions
Keywords
aneurysms, vascular disease, E-liac Stent Graft, E-liac Stent Graft System, iliac aneurysm, branched stent graft, self expanding stent graft
Brief summary
The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.
Interventions
DEVICEE-liac Stent Graft System
Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft
Sponsors
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must comply with the indications for use * Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm * Unsuitable distal sealing site within the common iliac artery for traditional EVAR
Exclusion criteria
* 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 * Patients with pseudoaneurysms * Patients with symptomatic and ruptured iliac aneurysms * Patients with one of the contraindications as indicated in the instructions for use * Patients pretreated with a bifurcated vascular graft * Patient with thrombocytopenia * Patient with creatinine \>2.4 mg/dl immediately before the intervention * Patient with malignancy needing chemotherapy or radiation * Patients who are enrolled in another clinical study * Patients with life expectancy of less than 36 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | within 30 days | Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side |
| Primary Patency | 12 months | — |
| Endoleak Type I or III | within 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Stent graft dislodgement | 36 months |
| Distal embolization | 36 months |
| Stent graft kinking | 36 months |
| Rate of complications | 36 months |
| Rate of death | 36 months |
| Change in aneurysm size | within 30 days (baseline) and 36 months |
| Stent graft migration | within 30 days (baseline) and 36 months |
Countries
Austria, Germany, Poland, Spain
Outcome results
None listed