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

May 18, 2022 updated by: JOTEC GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU Nantes
      • Rennes, France, 35033
        • CHU Pontchaillou
  • Germany
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Szpital Uniwersytecki im. dr. Antoniego Jurasza
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Warszawa, Poland, 02-097
        • Samodzielny Publiczny Centralny Szpital Kliniczny
  • Spain
      • Tarragona, Spain
        • Hospital Joan XXIII
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario Valladolid
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital - Universitätsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of aneurysm rupture and aneurysm related death
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOTEC GmbH

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECURE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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