Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

Study Overview
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Brief Summary
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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.

Official Title
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PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System

Conditions
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Iliac Aneurysm

Intervention / Treatment
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* Device: E-liac Stent Graft System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortoiliac Aneurysms Iliac Aneurysms<br>Endovascular repair of aortoiliac or iliac aneurysms | Device: E-liac Stent Graft System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side | within 30 days | 
| Primary Patency |  | 12 months | 
| Primary patency |  | 36 months | 
| Endoleak Type I or III |  | within 30 days | 
| Endoleak Type I or III |  | 12 months | 
| Endoleak Type I or III |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aneurysm size |  | within 30 days (baseline) and 36 months | 
| Stent graft migration |  | within 30 days (baseline) and 36 months | 
| Stent graft dislodgement |  | 36 months | 
| Stent graft kinking |  | 36 months | 
| Distal embolization |  | 36 months | 
| Rate of death |  | 36 months | 
| Rate of complications |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysms, vascular disease, E-liac Stent Graft, E-liac Stent Graft System, iliac aneurysm, branched stent graft, self expanding stent graft