In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
Study Type
OBSERVATIONAL
Enrollment
117
Antwerp University Hospital
Antwerp, Belgium
Binary restenosis
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio \> 2.4).
Time frame: 12 months
Immediate procedural outcome (procedural, technical and device success)
Procedural success: combination of technical success, device success and absence of procedural complications. Technical success: successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography. Device success: exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and in case of digital substraction angiography, in at least two different imaging projections.
Time frame: peri-procedural
Distribution of Rutherford stages
Time frame: 12 months
Primary sustained clinical improvement
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
Time frame: 12 months
Secondary sustained clinical improvement at 12 months
Defined as sustained upward shift of at least one category on the Rutherford classification including the need for repeated TLR in surviving patients.
Time frame: 12 months
Mortality
post-procedural
Time frame: 30-day mortality
Mortality
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Time frame: 12 months
Repeated target lesion revascularization (TLR) rate
Time frame: 12 months
Repeated target extremity revascularization (TER) rate
Time frame: 12 months
Amputation rate
Time frame: 12 months
Rate of patient clopidogrel resistance
Time frame: 1 month