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

JOTEC

Status: Completed

Conditions: Iliac Aneurysm

Treatments: Device: E-liac Stent Graft System

Study type: Observational

Funder types: Industry

Identifiers

NCT02209194

PLIANT

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

47 participants in 1 patient group

Aortoiliac Aneurysms Iliac Aneurysms

Description:

Endovascular repair of aortoiliac or iliac aneurysms

Treatment:

Device: E-liac Stent Graft System