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

• ClinicalTrials.gov Identifier: NCT02485496
• Recruitment Status: Terminated
• First Posted: June 30, 2015
• Last Update Posted: May 25, 2022
• Sponsor: JOTEC GmbH
• Information provided by (Responsible Party): JOTEC GmbH

Tracking Information

• First Submitted Date: June 26, 2015
• First Posted Date: June 30, 2015
• Last Update Posted Date: May 25, 2022
• Study Start Date: June 2015
• Actual Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 26, 2015): Rate of aneurysm rupture and aneurysm related death [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Abdominal Aortic Aneurysm
• AAA

Intervention

Device: Endovascular abdominal repair

Other Name: EVAR

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 18, 2022): 38
• Original Estimated Enrollment (submitted: June 26, 2015): 100
• Actual Study Completion Date: December 2021
• Actual Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Poland, Spain, Switzerland

Administrative Information

• NCT Number: NCT02485496
• Other Study ID Numbers: SECURE
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: JOTEC GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: JOTEC GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sven Seifert, Dr.; Klinikum Chemnitz

• PRS Account: JOTEC GmbH
• Verification Date: May 2022