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E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

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Disease Information

Descriptive Information
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.
Detailed Description
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Rate of aneurysm rupture and aneurysm related death
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm AAA
Intervention † DeviceEndovascular abdominal repair
Study Arms / Comparison Groups
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 October 2019
Primary Completion Date October 2017
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 †† Heike Fischer, Dr., +49 151 153 97 110, heike.fischer@jotec.com
Location Countries † France
Administrative Information
NCT ID † NCT02485496
Organization ID SECURE
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † JOTEC GmbH
Collaborators ††
Investigators † Principal Investigator: Sven Seifert, Dr., Klinikum Chemnitz
Information Provided By
Verification Date February 2016
First Received Date † June 26, 2015
Last Updated Date March 6, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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