Abdominal Aortic Aneurysm Clinical Trial
— SECUREOfficial title:
SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
NCT number | NCT02485496 |
Other study ID # | SECURE |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | December 2021 |
Verified date | May 2022 |
Source | JOTEC GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 38 |
Est. completion date | December 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Nantes | Nantes | |
France | CHU Pontchaillou | Rennes | |
Germany | Klinikum Chemnitz | Chemnitz | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Poland | Szpital Uniwersytecki im. dr. Antoniego Jurasza | Bydgoszcz | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 | Lublin | |
Poland | Samodzielny Publiczny Centralny Szpital Kliniczny | Warszawa | |
Spain | Hospital Joan XXIII | Tarragona | |
Spain | Hospital Clinico Universitario Valladolid | Valladolid | |
Switzerland | Inselspital - Universitätsspital | Bern |
Lead Sponsor | Collaborator |
---|---|
JOTEC GmbH |
France, Germany, Poland, Spain, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of aneurysm rupture and aneurysm related death | 2 years |
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