A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System (NCT04765176) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
Netherlands151 participantsStarted 2021-03-01
Plain-language summary
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18
* Patient must have an infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
* Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
* Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
* Patient understands and has signed the Informed Consent Form prior to intervention
* Patient has a life expectancy of at least 5 years
Exclusion Criteria:
* Patient with severe calcification or thrombi in the proximal sealing zone
* Patient with infectious aneurysm
* Patient with inflammatory aneurysm
* Patient with pseudoaneurysm
* Patient with symptomatic aneurysm
* Patient with ruptured or traumatic aneurysm
* Patient with suprarenal, juxtarenal, or pararenal aneurysm
* Patient with aortic dissection
* Patient with a reversed conical neck that is defined as a \> 3 mm distal increase over a 15 mm length
* Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company.
* Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft
* Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels
* Patient who is planned to be…