Phase
Condition
Aneurysm
Treatment
ECG-gated CTAs
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 65
Patient must have an
infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm inmales, or
infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cmper year
Patient is elegible for treatment inside the instructions for use of the E-tegraStent Graft System
Patient is able and willing to undergo follow-up imaging and examinations prior todischarge from the hospital, at 30 days and 6 months, 12 months, and annuallythereafter 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
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 increaseover a 15 mm length
Patient in which the E-tegra Stent Graft System is used in combination with proximalor distal extenders of another company.
Patient who is planned to be treated with an adjunctive aortic bare metal stent or afenestrated stent graft
Patient who is planned to be treated with a chimney / chimneys in the renal orvisceral vessels
Patient who is planned to be treated with an iliac branch device or parallel graftsin the iliac vessels
Patient with genetic connective tissue disease (e.g. Marfan syndrome orEhlers-Danlos syndrome)
Patient with eGFR < 45 ml/min/1.73 m2 before the intervention Patient had or plannedto have a major surgical or interventional procedure within 30 days before or 30days after the planned implantation of the E-tegra Stent Graft System
Patient with other medical condition that may cause the patient to be non-compliantwith the protocol, confound the results, or is associated with a limited lifeexpectancy 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 allowinclusion in this trial
Study Design
Study Description
Connect with a study center
Meander Medisch Centrum
Amersfoort, 3813 TZ
NetherlandsSite Not Available
Rijnstate Hospital
Arnhem, 6815 AD
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede, 7512 KZ
NetherlandsSite Not Available
Zuyderland Hospital
Heerlen,
NetherlandsSite Not Available
Elisabeth Tweesteden Ziekenhuis
Tilburg, 5022 GC
NetherlandsSite Not Available
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