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

"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

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)

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: VascuFlex Multi-LOC®

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany
    • Diakonissenkrankenhaus Mannheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion revascularization	target lesion revascularization surgical & interventional	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain free walking distance	pain free walking distance	< 3 weeks, 6 months, 12 months
maximum walking distance	maximum walking distance	< 3 weeks, 6 months, 12 months
target lesion revascularization	target lesion revascularization	12 months
procedural success	procedural success to pass and treat the target lesion	immediately after Multi-LOC implantation (within the first 30 minutes)
ankle brachial index	ankle brachial index	< 3 weeks, 6 months, 12 months
patency rates	patency rates observed using non-invasive Duplex ultrasound	6 and 12 months
Rutherford classification	Rutherford classification	baseline, < 3 weeks, 6 months, 12 months
Rutherford classification shift	difference in Rutherford classification compared to previous time point	< 3 weeks, 6 months, 12 months
amputation rate	rate of major and minor amputations	6 and 12 months
quality of life assessment	quality of life assessment through validates CRF's	6 and 12 months

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Collaborators: Deaconess Hospital Mannheim

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (ESTIMATE): August 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: AAG-O-H-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED