An observational study in Peripheral Arterial Occlusive Disease, sponsored by B. Braun Melsungen AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by B. Braun Melsungen AG · Observational
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)
296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.
This study's enrollment of 353 is above the median of 183 across 75 observational studies indexed under Arterial Occlusive Diseases.
Browse Arterial Occlusive Diseases studies →B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
(Lesions separated by less than 2 cm are considered as one lesion)
Exclusion Criteria:
Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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B. Braun Melsungen AG