Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
177
Self-expanding stent and standard PTA balloon
Standard PTA balloon
Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
Patency of the target lesion
Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
Time frame: up to 6 months after randomization
Freedom from perioperative death
Freedom from perioperative death
Time frame: up to 30 days after randomization
Freedom from major adverse limb event
Freedom from major adverse limb event
Time frame: up to 6 months after randomization
Freedom from major amputation above the ankle
Freedom from major amputation (above the ankle)
Time frame: up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
Reduction in size of ischemic leg/foot ulcers
Time frame: up to 6 months after randomization
Freedom from major adverse limb event
Freedom from major adverse limb event
Time frame: From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure related adverse events
Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.
Time frame: From date of randomization until the date of death from any cause assessed up to 36 months
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