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

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ClinicalTrials.gov Identifier: NCT02485496
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
JOTEC GmbH

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 Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Endovascular abdominal repair
    Other Name: EVAR


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


Information from the National Library of Medicine

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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

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


Contacts
Contact: Heike Fischer, Dr. +49 151 153 97 110 heike.fischer@jotec.com

Locations
France
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Yann Goueffic, Prof.    +33240165716      
CHU Pontchaillou Recruiting
Rennes, France, 35033
Contact: Adrien Kaladji, Dr.    +33 299287204      
Germany
Klinikum Chemnitz Recruiting
Chemnitz, Germany, 09116
Contact: Sven Seifert, Dr.    +49 371 333 43434      
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Dierk Scheinert, Prof.    +49 341 9718770      
Poland
Szpital Uniwersytecki im. dr. Antoniego Jurasza Recruiting
Bydgoszcz, Poland, 85-094
Contact: Arkadiusz Jawien, Professor    +48 601 168 423      
Samodzielny Publiczny Szpital Kliniczny Nr 1 Recruiting
Lublin, Poland, 20-081
Contact: Waclaw Karakula, Dr.    +48 605 094 800      
Samodzielny Publiczny Centralny Szpital Kliniczny Recruiting
Warszawa, Poland, 02-097
Contact: Tomasz Jakimowicz, Dr.    +48 601 168 423      
Samodzielny Publiczny Centralny Szpital Kliniczny Recruiting
Warszawa, Poland, 02-097
Contact: Zbigniew Galazka, Prof.    +48601363547      
Spain
Hospital Joan XXIII Recruiting
Tarragona, Spain
Contact: Benet Gómez Moya, Dr.    +34649826508      
Hospital Clinico Universitario Valladolid Recruiting
Valladolid, Spain, 47005
Contact: Carlos Vaquero Puerta, Prof.    +34606701006      
Switzerland
Inselspital - Universitätsspital Recruiting
Bern, Switzerland, 3010
Contact: Jürg Schmidli, Prof.    +41316322111      
Sponsors and Collaborators
JOTEC GmbH
Investigators
Principal Investigator: Sven Seifert, Dr. Klinikum Chemnitz

Responsible Party: JOTEC GmbH
ClinicalTrials.gov Identifier: NCT02485496     History of Changes
Other Study ID Numbers: SECURE
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases