"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE)

B. Braun

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Device: VascuFlex Multi-LOC®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02531230

AAG-O-H-1502

Details and patient eligibility

About

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)

Full description

This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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