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Trial record 1 of 1 for:    A post-market registry in patients with infrarenal aortic aneurysm undergoing endovascular stenting with the new E-tegra Stent Graft System
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E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (SECURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485496
Recruitment Status : Terminated (Due to product change.)
First Posted : June 30, 2015
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
JOTEC GmbH

Study Description
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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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm AAA Device: Endovascular abdominal repair

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
Study Start Date : June 2015
Actual Primary Completion Date : July 2020
Actual Study Completion Date : December 2021

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Groups and Cohorts
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Intervention Details:
  • Device: Endovascular abdominal repair
    Other Name: EVAR

Outcome Measures
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Primary Outcome Measures :
  1. Rate of aneurysm rupture and aneurysm related death [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485496


Locations
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France
CHU Nantes
Nantes, France, 44093
CHU Pontchaillou
Rennes, France, 35033
Germany
Klinikum Chemnitz
Chemnitz, Germany, 09116
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Poland
Szpital Uniwersytecki im. dr. Antoniego Jurasza
Bydgoszcz, Poland, 85-094
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland, 20-081
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland, 02-097
Spain
Hospital Joan XXIII
Tarragona, Spain
Hospital Clinico Universitario Valladolid
Valladolid, Spain, 47005
Switzerland
Inselspital - Universitätsspital
Bern, Switzerland, 3010
Sponsors and Collaborators
JOTEC GmbH
Investigators
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Principal Investigator: Sven Seifert, Dr. Klinikum Chemnitz
More Information
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Responsible Party: JOTEC GmbH
ClinicalTrials.gov Identifier: NCT02485496    
Other Study ID Numbers: SECURE
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases