EASYII - A Post-Market Clinical Follow-up Study (PMCF) in patients with infrarenal aortic aneurysm undergoing endovascular stenting with the E-tegra Stent Graft System - imaging cohort
- Conditions
- infrarenal aortic aneurysmwidening of abdominal aorta10002363
- Registration Number
- NL-OMON55918
- Lead Sponsor
- JOTEC GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria:
* Age >= 65
* Patient must have an
o infrarenal aortic aneurysm with diameter >= 50 mm in females and >= 55 mm in
males, or
o 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 6 months, 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 treated with an iliac branch device or parallel
grafts in the iliac vessels
* Patient with genetic connective tissue disease (e.g. Marfan syndrome or
Ehlers-Danlos syndrome)
* Patient with eGFR < 45 ml/min/1.73 m2 before the intervention
* Patient had or planned to have a major surgical or interventional procedure
within 30 days before or 30 days after the planned
implantation of the E-tegra Stent Graft System
* Patient with other medical condition that may cause the patient to be
non-compliant with the protocol, confound the results, or is associated with a
limited life expectancy of less than five years (i.e. heart failure, active
malignancy (progressive, stable or partial remission))
* Patient who has been enrolled in another active clinical trial that does not
allow inclusion in this trial
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endpoint:<br /><br>• Rate of 30-day mortality<br /><br><br /><br>Primary Imaging Endpoint:<br /><br>• Quantifying stent stability and durability as well as the seal of the stent<br /><br>graft during the cardiac cycle and over time at 30 day follow-up</p><br>
- Secondary Outcome Measures
Name Time Method