To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or who are at high risk of migration or endoleak complications post-procedure, and to support product registration of Heli-FX EndoAnchor system with the National Medical Product Administration (NMPA) in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment
Beijing Anzhen Hospital Capital Medical University
Beijing, China
RECRUITINGPrimary Effectiveness Endpoint
Composite treatment endpoint of Heli-FX within 12 months: * Technical success * No Type Ia endoleak * No endograft migration of proximal stent graft component * No aortic aneurysm rupture
Time frame: From procedure to 12 months after index procedure
Primary Safety Endpoint
Percentage of patients experiencing one or more major adverse events (MAE) within 30 days post-operation. MAEs are defined as any of the following: * All-cause mortality (ACM) * Heli-FX device-related serious adverse event (SAE) * Myocardial infarction (MI) * Stroke (excluding transient ischemic attacks) * Renal failure (excluding renal insufficiency) * Respiratory failure
Time frame: within 30 days post-operation
Secondary Endpoints
* Technical success and clinical success at the time of index procedure * All-cause mortality and aneurysm-related mortality at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years. * Type Ia endoleak at 30 days, 6 months, one year, and annually through 3 years * Endograft migration at 6 months, one year, and annually through 3 years * Aneurysm sac change by diameter at 6 months, one year and annually through 3 years compared to the CT(Computed Tomography) imaging at 30 days after index procedure * Loss of endograft fabric integrity as a result of the EndoAnchor implant, rupture of the treated aneurys, conversion to open surgical repair at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years * Myocardial infarction, stroke (excluding transient ischemic attacks), renal failure and respiratory failure at 30 days, 6 months, one year, and annually through 3 years
Time frame: From index-procedure to 3 years
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