This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries.
The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGprimary patency
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Time frame: 12 months
Major Adverse Event
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death, myocardial infarction (MI), target lesion revascularization (TLR) or major amputation of the target limb.
Time frame: 36 months
Secondary Patency
The secondary patency of target lesion at 6, 12, 24, and 36 Months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Time frame: 6, 12, 24, and 36 Months
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