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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485496
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : August 15, 2019
Sponsor:
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 August 15, 2019
Study Start Date June 2015
Estimated Primary Completion Date December 2019   (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
Change History Complete list of historical versions of study NCT02485496 on ClinicalTrials.gov Archive Site
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2015)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2019   (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: Heike Fischer, Dr. +49 151 153 97 110 heike.fischer@jotec.com
Listed Location Countries France,   Germany,   Poland,   Spain,   Switzerland
Removed Location Countries  
 
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
Responsible Party JOTEC GmbH
Study Sponsor JOTEC GmbH
Collaborators Not Provided
Investigators
Principal Investigator: Sven Seifert, Dr. Klinikum Chemnitz
PRS Account JOTEC GmbH
Verification Date August 2019