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

Completed

• Conditions: Iliac Aneurysm
• Interventions: Device: E-liac Stent Graft System

• Registration Number: NCT02209194
• Lead Sponsor: JOTEC GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortoiliac Aneurysms Iliac Aneurysms	E-liac Stent Graft System	Endovascular repair of aortoiliac or iliac aneurysms

Primary Outcome Measures

Name	Time	Method
Primary patency	36 months
Primary Patency	12 months
Endoleak Type I or III	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Uniklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

UKSH Campus Kiel; 🇩🇪 Kiel, Germany

Herzzentrum Hietzing; 🇦🇹 Wien, Austria

Klinikum Chemnitz; 🇩🇪 Chemnitz, Germany

Krankenhaus Leonberg; 🇩🇪 Leonberg, Germany

Wilhelminenspital; 🇦🇹 Wien, Austria

Cologne University Hospital; 🇩🇪 Cologne, Germany

German Heart Center; 🇩🇪 Berlin, Germany

Marienhospital; 🇩🇪 Osnabrück, Germany

Instytut Hematologii i Transfuzjologii; 🇵🇱 Warszawa, Poland

Hospital Universitario Donostia; 🇪🇸 San Sebastian, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain