a bulge in a part of the aorta cardiovascular disease
Conditions
Interventions
Endologix Fenestrated JAA/PAA proximal extension stent graft devices
Endologix renal stent graft devices
Sponsors
Endologix Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female at least 18 years old; informed consent understood and signed and patient agrees to all follow-up visits; have aortic aneurysm with maximum diameter *5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than normal aortic diameter. Anatomically eligible for the Endologix Bifurcated System per the FDAapproved indications for use (IFU) and for the Fenestrated Stent Graft System.
Exclusion criteria
Exclusion criteria: Life expectancy 2.0 mg/dL;Traumatic vascular injury; Active systemic or localized groin infection; Connective tissue disease (e.g., Marfan*s Syndrome); Recent (within prior three months) cerebrovascular accident or myocardial infarction; Prior renal transplant; Length of either renal artery to be stented 70%); An essential accessory renal artery; Indispensable inferior mesenteric artery; Untreated aneurysmal disease of the descending thoracic aorta; Prior iliac artery stent implanted that may interfere with delivery system introduction; Unsuitable vascular anatomy; Pregnancy (female patient of childbearing potential only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Major adverse events at 1 month. Feasibility: Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak at 1 month. Procedural, clinical, and assisted clinical feasibility will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional evaluations include: * Procedural and in-hospital evaluations: Anesthesia time; fluoroscopy time; contrast volume used; total procedure time; estimated blood loss; % of patients with transfusion; time in ICU; time to hospital discharge. * Death (all-cause and aneurysm-related) within 30 days, at 6 months, and annually at 1 to 5 years; * Major adverse events after 30 days, at 6 months, and annually at 1 to 5 years; * Individual major adverse event components within 30 days, at 6 months, and annually at 1 to 5 years; * Aneurysm rupture within 30 days, at 6 months, and annually at 1 to 5 years; * Conversion to open repair within 30 days, at 6 months, and annually at 1 to 5 years; * Adverse Events: All serious and non-serious events within 30 days, at 6 months, and annually at 1 to 5 years; * Distal blood flow (ankle-brachial index evaluations) pre-discharge and at 30 days, 6 months, and annually at 1 to 5 years; * Endograft performance (aneurysm sac diameter changes; device migration; incidence of endoleak) at 30 days, 6 months, and annually at 1 to 5 years; * Renal function as assessed by estimated glomerular filtration rate (eGFR) pre-discharge and at 30 days, 6 months, and annually at 1 to 5 years; * Renal stent graft patency and integrity at 30 days, 6 months, and annually at 1 to 5 years; * Stent graft (fenestrated/bifurcated) patency and integrity at 30 days, 6 months, and annually at 1 to 5 years; * Secondary procedures within 30 days, at six months, and at years 1through 5 for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. | — |
Countries
Netherlands
Outcome results
None listed