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NCT02485496 Clinical Trial

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

Abdominal Aortic Aneurysm Clinical Trial

— SECURE  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02485496
Other study ID # SECURE
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 2015
Est. completion date December 2021

Study information
Verified date May 2022
Source JOTEC GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 38
Est. completion date December 2021
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endovascular abdominal repair

Locations
Country Name City State
France CHU Nantes Nantes
France CHU Pontchaillou Rennes
Germany Klinikum Chemnitz Chemnitz
Germany Universitätsklinikum Leipzig Leipzig
Poland Szpital Uniwersytecki im. dr. Antoniego Jurasza Bydgoszcz
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 Lublin
Poland Samodzielny Publiczny Centralny Szpital Kliniczny Warszawa
Spain Hospital Joan XXIII Tarragona
Spain Hospital Clinico Universitario Valladolid Valladolid
Switzerland Inselspital - Universitätsspital Bern

Sponsors (1)
Lead Sponsor Collaborator
JOTEC GmbH

Countries where clinical trial is conducted

France,  Germany,  Poland,  Spain,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of aneurysm rupture and aneurysm related death 2 years
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