ClinicalTrials.gov

History of Changes for Study: NCT02485496
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (SECURE)
Latest version (submitted May 18, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 26, 2015 None (earliest Version on record)
2 September 22, 2015 Contacts/Locations and Study Status
3 February 23, 2016 Study Status and Contacts/Locations
4 August 29, 2016 Contacts/Locations and Study Status
5 March 6, 2017 Study Status
6 March 9, 2018 Study Status
7 August 14, 2019 Study Status
8 April 29, 2020 Study Status
9 February 18, 2021 Study Status
10 May 18, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02485496
Submitted Date:  June 26, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: SECURE
Brief Title: E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2015
Overall Status: Recruiting
Study Start: June 2015
Primary Completion: February 2016 [Anticipated]
Study Completion: July 2018 [Anticipated]
First Submitted: June 26, 2015
First Submitted that
Met QC Criteria:
June 26, 2015
First Posted: June 30, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 26, 2015
Last Update Posted: June 30, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: JOTEC GmbH
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Abdominal Aortic Aneurysm
AAA
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 100 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Device: Endovascular abdominal repair
Other Names:
  • EVAR
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of aneurysm rupture and aneurysm related death
[ Time Frame: 2 years ]

Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Heike Fischer, Dr.
Telephone: +49 151 153 97 110
Email: heike.fischer@jotec.com
Study Officials: Sven Seifert, Dr.
Principal Investigator
Klinikum Chemnitz
Locations: Germany
Klinikum Chemnitz
[Recruiting]
Chemnitz, Germany, 09116
Contact:Contact: Sven Seifert, Dr. +49 371 333 43434
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services