Clinical trial NCT02531230: "All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes
Official title: "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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
Collaborators: name: Deaconess Hospital Mannheim
First posted: 2015-08-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

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)

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patient not suitable for revascularization by interventional means

Primary outcomes:
measure: target lesion revascularization
timeFrame: 6 months
Secondary outcomes:
measure: pain free walking distance
timeFrame: < 3 weeks, 6 months, 12 months
measure: maximum walking distance
timeFrame: < 3 weeks, 6 months, 12 months
measure: target lesion revascularization
timeFrame: 12 months
measure: procedural success
timeFrame: immediately after Multi-LOC implantation (within the first 30 minutes)
measure: ankle brachial index
timeFrame: < 3 weeks, 6 months, 12 months
measure: patency rates
timeFrame: 6 and 12 months
measure: Rutherford classification
timeFrame: baseline, < 3 weeks, 6 months, 12 months
measure: Rutherford classification shift
timeFrame: < 3 weeks, 6 months, 12 months
measure: amputation rate
timeFrame: 6 and 12 months
measure: quality of life assessment
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Diakonissenkrankenhaus Mannheim
Study officials:
affiliation: Deaconess Hospital Mannheim
name: Klaus Amendt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sigl M, Beschorner U, Zeller T, Waliszewski M, Langhoff R, Tautenhahn J, Amendt K. Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study. Cardiovasc Intervent Radiol. 2019 Feb;42(2):169-175. doi: 10.1007/s00270-018-2095-9. Epub 2018 Oct 25.