"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)
- Conditions
- Peripheral Arterial Occlusive Disease
- Registration Number
- NCT02900274
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
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)
- Detailed Description
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method target lesion revascularization 6 months target lesion revascularization surgical \& interventional
- Secondary Outcome Measures
Name Time Method pain free walking distance < 3 weeks, 6 months, 12 months pain free walking distance
maximum walking distance < 3 weeks, 6 months, 12 months maximum walking distance
ankle brachial index < 3 weeks, 6 months, 12 months ankle brachial index
quality of life assessment 6 and 12 months quality of life assessment through validates CRF's
target lesion revascularization 12 months target lesion revascularization
procedural success immediately after Multi-LOC implantation (within the first 30 minutes) procedural success to pass and treat the target lesion
patency rates 6 and 12 months patency rates observed using non-invasive Duplex ultrasound
Rutherford classification baseline, < 3 weeks, 6 months, 12 months Rutherford classification
Rutherford classification shift < 3 weeks, 6 months, 12 months difference in Rutherford classification compared to previous time point
amputation rate 6 and 12 months rate of major and minor amputations
Trial Locations
- Locations (1)
Diakonissenkrankenhaus Mannheim
🇩🇪Mannheim, Germany