E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Terminated
- Conditions
- AAAAbdominal Aortic Aneurysm
- Registration Number
- NCT02485496
- Lead Sponsor
- JOTEC GmbH
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of aneurysm rupture and aneurysm related death 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Inselspital - Universitätsspital
🇨🇭Bern, Switzerland
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warszawa, Poland
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital Clinico Universitario Valladolid
🇪🇸Valladolid, Spain
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Lublin, Poland
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
CHU Nantes
🇫🇷Nantes, France
CHU Pontchaillou
🇫🇷Rennes, France
Klinikum Chemnitz
🇩🇪Chemnitz, Germany
Szpital Uniwersytecki im. dr. Antoniego Jurasza
🇵🇱Bydgoszcz, Poland