Clinical trial NCT02485496: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysm
AAA
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with infrarenal aortic or aorto-iliac aneurysm who are eligible for treatment with an abdominal stent graft according to the instructions for use for the E-tegra stent graft system, and scheduled for implantation of the E-tegra stent graft system at their physician's discretion in accordance with the inclusion and exclusion criteria.

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.


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

Primary outcomes:
measure: Rate of aneurysm rupture and aneurysm related death
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
city: Rennes
country: France
facility: CHU Pontchaillou
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario Valladolid
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital
Study officials:
affiliation: Klinikum Chemnitz
name: Sven Seifert, Dr.
role: PRINCIPAL_INVESTIGATOR
References: