NCT02209194
Completed
Not Applicable
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
ConditionsIliac Aneurysm
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Iliac Aneurysm
- Sponsor
- JOTEC GmbH
- Enrollment
- 47
- Locations
- 12
- Primary Endpoint
- Primary patency
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Primary patency
Time Frame: 36 months
Primary Patency
Time Frame: 12 months
Endoleak Type I or III
Time Frame: 36 months
Secondary Outcomes
- Rate of complications(36 months)
- Stent graft migration(within 30 days (baseline) and 36 months)
- Stent graft dislodgement(36 months)
- Distal embolization(36 months)
- Rate of death(36 months)
- Change in aneurysm size(within 30 days (baseline) and 36 months)
- Stent graft kinking(36 months)
Study Sites (12)
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