E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (NCT02485496) | Clinical Trial Compass
TerminatedNot Applicable
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Stopped: Due to product change.
France, Germany, Poland38 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of aneurysm rupture and aneurysm related death