Brief Title
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Official Title
SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
Brief Summary
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.
Study Type
Observational
Primary Outcome
Rate of aneurysm rupture and aneurysm related death
Condition
Abdominal Aortic Aneurysm
Intervention
Endovascular abdominal repair
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
June 2015
Completion Date
December 2021
Primary Completion Date
July 2020
Eligibility Criteria
Inclusion 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 Exclusion Criteria: - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sven Seifert, Dr., +49 151 153 97 110, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02485496
Organization ID
SECURE
Responsible Party
Sponsor
Study Sponsor
JOTEC GmbH
Study Sponsor
Sven Seifert, Dr., Principal Investigator, Klinikum Chemnitz
Verification Date
April 2020