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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02485496

Acronym

SECURE

Enrollment

Registered

2015-06-30

Start date

2015-06-30

Completion date

2021-12-31

Last updated

2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AAA, Abdominal Aortic Aneurysm

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.

Interventions

DEVICEEndovascular abdominal repair

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of aneurysm rupture and aneurysm related death	2 years

Countries

France, Germany, Poland, Spain, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026