Status:
COMPLETED
Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
Lead Sponsor:
JOTEC GmbH
Conditions:
Iliac Aneurysm
Eligibility:
All Genders
18+ years
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 aortoi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02209194
Start Date
June 1 2014
End Date
September 1 2019
Last Update
May 1 2020
Active Locations (12)
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1
Herzzentrum Hietzing
Vienna, Austria, 1130
2
Wilhelminenspital
Vienna, Austria, 1160
3
German Heart Center
Berlin, Germany, 13353
4
Klinikum Chemnitz
Chemnitz, Germany, 09113