E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (SECURE)
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ClinicalTrials.gov Identifier: NCT02485496
Recruitment Status :
(Due to product change.)
The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female patients with infrarenal aortic or aorto-iliac aneurysm who are eligible for treatment with an abdominal stent graft according to the instructions for use for the E-tegra stent graft system, and scheduled for implantation of the E-tegra stent graft system at their physician's discretion in accordance with the inclusion and exclusion criteria.
Patients must comply with the indications for use
Patient must have an infrarenal aortic aneurysm with diameter >5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
Patient must be available for the appropriate follow-up times for the duration of the study
Patient has signed the informed consent before intervention
Patients with one of the contraindications as indicated in the instructions for use
Patients with infectious aneurysm
Patients with inflammatory aneurysm
Patients with pseudoaneurysm
Patients with ruptured or traumatic aneurysm
Patients with suprarenal, juxtarenal, or pararenal aneurysm
Patients with aortic dissection
Patients with a reversed conical neck that is defined as a >3mm distal increase over a 15mm length
Patients who have a congenital degenerative Collagen disease or connective tissue disorder
Patients with thrombocytopenia
Patients with creatinine >2.4 mg/dl immediately before the Intervention
Patients with hyperthyreosis
Patients with malignancy needing chemotherapy or Radiation
Patients who are enrolled in another clinical study
Patients with life expectancy of less than 24 months