dilatation of the abdominal aorta Enlarged artery of the abdominal aorta
Conditions
Interventions
Patients with an indication for treatment of their infrarenal abdominal aortic
aneurysm will be treated with the Nellix system according to the instructions
for use.
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; *Patient agrees to all follow-up visits; *Have an infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter *5.5cm, or an infrarenal AAA * 4.5 cm which has increased by >1.0cm in the past year. *Anatomic eligibility for the Nellix System per the instructions for use: oAdequate iliac/femoral access compatible with the required delivery systems (diameter 6 mm); oAneurysm blood lumen diameter *60mm; oProximal non-aneurysmal aortic neck: * length 10mm; * lumen diameter 16 to 32mm; * angle 60° to the aneurysm sac; oMost caudal renal artery to each hypogastric artery length 100mm; oCommon iliac artery lumen diameter between 8 and 35mm; oAbility to preserve at least one hypogastric artery.
Exclusion criteria
Exclusion criteria: * Life expectancy 2.0mg/dL; * CVA or MI within three months of enrollment/treatment; * Aneurysmal disease of the descending thoracic aorta; * Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference); * Connective tissue diseases (e.g., Marfan Syndrome) * Unsuitable vascular anatomy; * Pregnant (females of childbearing potential only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6.1. PRIMARY SAFETY The safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following. Event definitions are provided in §8.7.7. * All-Cause Mortality; * Bowel Ischemia; * Myocardial Infarction; * Paraplegia; * Renal Failure; * Respiratory Failure; * Stroke; * Procedural Blood Loss *1,000mL 6.2. PRIMARY EFFECTIVENESS The primary effectiveness endpoint is defined as the rate of Treatment Success at one year. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows. Event and related definitions are provided in §8.7.7. Treatment Success: Procedural technical success and absence of: * Abdominal aortic aneurysm rupture; * Conversion to open surgical repair; * Endoleak Type I or III at 12 months; * Clinically significant migration; * Aneurysm enlargement; or * Secondary endovascular procedure up to 12 months for resolution of * Endoleak (Type I or Type III) * Device obstruction or occlusion * Device migration * Abdominal aneurysm sac expansion * Device defect. Refer to §10.7 for primary effectiveness endpoint analysis details. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional evaluations include: * Procedural and In-Hospital Evaluations: o Volume of contrast media used; o Estimated blood loss; o Fluoroscopy time; o % requiring blood transfusion; o Total procedure time; o Anesthesia time; o Time in ICU; o Time to hospital discharge; * Mortality, all-cause and aneurysm-related, within 30 days, at 6 months, and annually to 5 years; * MAE Individual Components within 30 days, at 6 months, and annually to 5 years; * Composite MAEs after 30 days, at 6 months, and annually to 5 years; * Aneurysm Rupture within 30 days, at 6 months, and annually to 5 years; * Conversion to Open Surgical Repair within 30 days, at 6 months, and annually to 5 years; * Adverse Events (serious and non-serious) within 30 days, at 6 months, and annually to 5 years; * Device Performance (aneurysm sac diameter change from the first post-operative visit; device migration; clinically significant device migration, incidence of endoleak) at 30 days, 6 months, and annually to 5 years; * Renal Function pre-discharge and at 30 days, 6 months, and annually to 5 years, as assessed by the estimated glomerular filtration rate (eGFR) and changes over time; * Device Patency and Integrity within 30 days, at 6 months, and annually to 5 years, as determined by contrast-enhanced CT scan, and as assessed by the independent core laboratory, inclusive of: o Patent luminal flow o Absence of kinking or occlusion o Absence of stent fracture o Absence of device failure * Luminal Thrombus Requiring Intervention within 30 days, at 6 months, and annually to 5 years; * Secondary Procedure within 30 days, at 6 months, and annually to 5 years for resolution of endoleak, device occlusion, migration, aneurysm sac expansion and/or a device defect. | — |
Countries
Netherlands
Outcome results
None listed