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Peripheral Arterial Occlusive DiseaseLOCOMOTIVENCT02531230

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

An observational study of Peripheral Arterial Occlusive Disease, run by B. Braun Melsungen AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Occlusive Disease
What is being tested?
VascuFlex Multi-LOC®
Type of treatment
Medical device
How many people
75 participants
Where
1 siteGermany
Study dates
Jul 2015to Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • Patient not suitable for revascularization by interventional means

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Diakonissenkrankenhaus Mannheim

    Mannheim

Other trials in Germany

About this study

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

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)

Read the detailed description

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

Being tested
VascuFlex Multi-LOC®
Medical subject headings
Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VascuFlex Multi-LOC®Device

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. target lesion revascularization

    target lesion revascularization surgical \& interventional

    Measured: 6 months

Secondary outcomes (10)

  1. pain free walking distance

    pain free walking distance

    Measured: < 3 weeks, 6 months, 12 months

  2. maximum walking distance

    maximum walking distance

    Measured: < 3 weeks, 6 months, 12 months

  3. target lesion revascularization

    target lesion revascularization

    Measured: 12 months

  4. procedural success

    procedural success to pass and treat the target lesion

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

  5. ankle brachial index

    ankle brachial index

    Measured: < 3 weeks, 6 months, 12 months

  6. patency rates

    patency rates observed using non-invasive Duplex ultrasound

    Measured: 6 and 12 months

  7. Rutherford classification

    Rutherford classification

    Measured: baseline, < 3 weeks, 6 months, 12 months

  8. Rutherford classification shift

    difference in Rutherford classification compared to previous time point

    Measured: < 3 weeks, 6 months, 12 months

  9. amputation rate

    rate of major and minor amputations

    Measured: 6 and 12 months

  10. quality of life assessment

    quality of life assessment through validates CRF's

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2016
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531230
Sponsor's protocol ID
AAG-O-H-1502
Acronym
LOCOMOTIVE
Status last verified
Oct 2018
First submitted
29 May 2015
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 30361959

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Occlusive Disease, run by B. Braun Melsungen AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target lesion revascularization (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531230, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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