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
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (SECURE)
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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
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Sponsor:
JOTEC GmbH
Information provided by (Responsible Party):
JOTEC GmbH
Tracking Information | |||||
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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 |
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 |
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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 |
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Intervention | Device: Endovascular abdominal repair
Other Name: EVAR
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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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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PRS Account | JOTEC GmbH | ||||
Verification Date | August 2019 |