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

NCT02531230 | Completed DMC

• 1 other identifier: AAG-O-H-1502
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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)

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• target lesion revascularization

  target lesion revascularization surgical \& interventional

  6 months

Secondary Outcomes (10)

• pain free walking distance

  < 3 weeks, 6 months, 12 months

• maximum walking distance

  < 3 weeks, 6 months, 12 months

• target lesion revascularization

  12 months

• procedural success

  immediately after Multi-LOC implantation (within the first 30 minutes)

• ankle brachial index

  < 3 weeks, 6 months, 12 months

Interventions

VascuFlex Multi-LOC® DEVICE

Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• Patient not suitable for revascularization by interventional means

Sponsors & Collaborators

• B. Braun Melsungen AG: lead
• Deaconess Hospital Mannheim: collaborator

Study Sites (1)

Diakonissenkrankenhaus Mannheim

Mannheim, Germany

Location

Related Publications (1)

• 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.

  PMID: 30361959 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Klaus Amendt, MD

  Deaconess Hospital Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: August 24, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

DE (1)