SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System

JOTEC GmbH10 sites in 5 countries38 target enrollmentJune 2015

ConditionsAbdominal Aortic Aneurysm AAA

Overview

Phase: N/A
Intervention: Not specified
Conditions: Abdominal Aortic Aneurysm
Sponsor: JOTEC GmbH
Enrollment: 38
Locations: 10
Primary Endpoint: Rate of aneurysm rupture and aneurysm related death
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

December 2021

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

JOTEC GmbH

Responsible Party

Sponsor

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