"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)
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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)
Condition or disease
Peripheral Arterial Occlusive Disease
Device: VascuFlex Multi-LOC®
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes After Plain Old Balloon Angioplasty (POBA) and/or Drug Coated Balloon (DCB) Treatment in the Infra-inguinal Position With the objectiVE to Implant Multiple Stent Segments
Study Start Date :
Actual Primary Completion Date :
Estimated Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions
Patients in Rutherford classes 2 through 5
Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting
Patients must be at least 18 years of age
Patient with a life expectance of at least 12 months
Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
Patients must agree to undergo at least the 6-month clinical follow-up
Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions
Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 & P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm
Diameter stenosis pre-procedure must be larger or equal to 70%
Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot.
(Lesions separated by less than 2 cm are considered as one lesion)
Patient not suitable for revascularization by interventional means