The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 \& P3)
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
Study Type
OBSERVATIONAL
Enrollment
353
Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
Diakonissenkrankenhaus Mannheim
Mannheim, Germany
target lesion revascularization
target lesion revascularization surgical \& interventional
Time frame: 6 months
pain free walking distance
pain free walking distance
Time frame: < 3 weeks, 6 months, 12 months
maximum walking distance
maximum walking distance
Time frame: < 3 weeks, 6 months, 12 months
target lesion revascularization
target lesion revascularization
Time frame: 12 months
procedural success
procedural success to pass and treat the target lesion
Time frame: immediately after Multi-LOC implantation (within the first 30 minutes)
ankle brachial index
ankle brachial index
Time frame: < 3 weeks, 6 months, 12 months
patency rates
patency rates observed using non-invasive Duplex ultrasound
Time frame: 6 and 12 months
Rutherford classification
Rutherford classification
Time frame: baseline, < 3 weeks, 6 months, 12 months
Rutherford classification shift
difference in Rutherford classification compared to previous time point
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: < 3 weeks, 6 months, 12 months
amputation rate
rate of major and minor amputations
Time frame: 6 and 12 months
quality of life assessment
quality of life assessment through validates CRF's
Time frame: 6 and 12 months