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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02531230
First Posted: August 24, 2015
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Diakonissenkrankenhaus Mannheim
Information provided by (Responsible Party):
B. Braun Melsungen AG
  Purpose
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)

Condition Intervention
Peripheral Arterial Occlusive Disease Device: VascuFlex Multi-LOC®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • target lesion revascularization [ Time Frame: 6 months ]
    target lesion revascularization surgical & interventional


Secondary Outcome Measures:
  • pain free walking distance [ Time Frame: < 3 weeks, 6 months, 12 months ]
    pain free walking distance

  • maximum walking distance [ Time Frame: < 3 weeks, 6 months, 12 months ]
    maximum walking distance

  • target lesion revascularization [ Time Frame: 12 months ]
    target lesion revascularization

  • procedural success [ Time Frame: immediately after Multi-LOC implantation (within the first 30 minutes) ]
    procedural success to pass and treat the target lesion

  • ankle brachial index [ Time Frame: < 3 weeks, 6 months, 12 months ]
    ankle brachial index

  • patency rates [ Time Frame: 6 and 12 months ]
    patency rates observed using non-invasive Duplex ultrasound

  • Rutherford classification [ Time Frame: baseline, < 3 weeks, 6 months, 12 months ]
    Rutherford classification

  • Rutherford classification shift [ Time Frame: < 3 weeks, 6 months, 12 months ]
    difference in Rutherford classification compared to previous time point

  • amputation rate [ Time Frame: 6 and 12 months ]
    rate of major and minor amputations

  • quality of life assessment [ Time Frame: 6 and 12 months ]
    quality of life assessment through validates CRF's


Enrollment: 75
Study Start Date: August 2015
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: VascuFlex Multi-LOC®
    Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
Detailed Description:
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531230


Locations
Germany
Diakonissenkrankenhaus Mannheim
Mannheim, Germany
Sponsors and Collaborators
B. Braun Melsungen AG
Diakonissenkrankenhaus Mannheim
Investigators
Principal Investigator: Klaus Amendt, MD Diakonissenkrankenhaus Mannheim
  More Information

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02531230     History of Changes
Other Study ID Numbers: AAG-O-H-1502
First Submitted: May 29, 2015
First Posted: August 24, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases