Status:
ACTIVE_NOT_RECRUITING
A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
Lead Sponsor:
JOTEC GmbH
Conditions:
Vascular Aneurysm
Eligibility:
All Genders
18+ years
Brief 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 aneurys...
Detailed Description
In this study, patients will be observed who receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2029
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04765176
Start Date
March 1 2021
End Date
October 1 2029
Last Update
July 25 2024
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Netherlands, 6815