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

JOTEC

Status: Terminated

Conditions: AAA; Abdominal Aortic Aneurysm

Treatments: Device: Endovascular abdominal repair

Study type: Observational

Funder types: Industry

Identifiers

NCT02485496

SECURE

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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