This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.
Study Type
OBSERVATIONAL
Enrollment
100
University Hospital Ghent
Ghent, Belgium
Absence of clinically driven target lesion revascularization at 12 months.
Time frame: 12 months
Technical success
Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.
Time frame: During procedure
Clinical success
Defined as technical success without the occurrence of serious adverse events during procedure
Time frame: During procedure
Primary and secondary patency rate
defined as \< 50% diameter reduction and peak systolic velocity \< 2.4 at 12 months.
Time frame: 12 months
Ankle-Brachial Index improvement of ≥ 0.1
Time frame: 1, 6 and 12 months
Clinically driven target vessel revascularization
Time frame: 6 and 12 months
Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.
Time frame: 6 and 12 months
Rutherford-Becker classification of chronic limb ischemia
Time frame: 1, 6 and 12 months
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