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Peripheral Arterial DiseaseMimicsNCT02163863

BioMimics 3D Stent Clinical Investigation: The Mimics Study

A study testing Femoropopliteal stenting in people with Peripheral Arterial Disease, run by Veryan Medical Ltd. 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

Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Femoropopliteal stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteGermany
Study dates
Feb 2010to Jul 2014
Phase
Interventional
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

Who may be able to join

  • >18 years of age
  • The subject or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent
  • The subject is willing to be available for the appropriate follow-up for the duration of the study
  • Rutherford 1-4(mild claudication to ischemic rest pain), with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ABI/TBI <0.90/0.80
  • Single target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur
  • Target vessel reference diameter is ≥3.5 mm and ≤7.0 mm
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  • Target lesion length is ≥4.0 cm and ≤10.0 cm, and must be intended to be covered with one single stent only. A second stent is permitted to be placed only if, in the physician's opinion, the first stent did not achieve an optimum clinical result
  • Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed
  • Life expectancy >24 months

Who cannot join

  • Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment (if not already post menopausal) or women who do not agree to use an adequate birth control method for up to 24 months after Device implantation
  • An uncontrolled infectious disease
  • A condition that inhibits radiographic visualisation of the arteries
  • Any condition that precludes safe access with PTA devices, such as: excessive common femoral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified
  • Known allergy to, or intolerance of, Nitinol
  • Known intolerance of aspirin and/or clopidogrel
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  • Known hypersensitivity to contrast media which cannot be pre-treated
  • Participation in another device or drug study. Subject must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this study. The subject may only be enrolled in this study once
  • The subject is unable and/or unwilling to cooperate with study procedures or required follow-up visits
  • History of bleeding diatheses or coagulopathy or will refuse blood transfusions
  • Known impaired renal function, defined as creatinine >2.5 mg/dl except subjects under chronic renal replacement therapy
  • Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3
  • Known WBC of <3,000 cells/mm3
  • The subject is unable to bend lower limbs (full knee flexion) and/or has a knee prosthesis
  • Previous treatment of the target lesion 6 months prior to enrollment; previous femoropopliteal bypass in the target vessel; previous stenting of the target lesion
  • Previous stenting of the SFA, popliteal and tibial arteries within the target limb
  • Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
  • Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure)
  • Lesions in contralateral SFA that require intervention during the index procedure, or within 30 days after the index procedure, unless both limbs are able to be and are included in the study
  • Multiple lesions in the target vessel that require stenting within 30 days after study procedure
  • Target lesion length is > 10cm or the physician believes prior to stent placement that the lesion cannot be covered by one single stent
  • The target lesion is severely calcified

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitaets-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen

Other trials in Germany

About this study

Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.

Read the detailed description

The Mimics Study is a prospective, part randomized study; an initial roll-in registry of 10 subjects treated with BioMimics 3D followed by a randomized assignment to treatment with BioMimics 3D or Control on a 2:1 basis for 76 subjects.

The primary purpose of the study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease based on:

  • Safety; measured by freedom from major adverse events determined at 30 days after the procedure, compared to historic controls.
  • Performance; measured by freedom from clinically driven TLR at 6 months, compared to historic controls.
Being tested
Femoropopliteal stenting
Keywords
Peripheral arterial disease (PAD), Peripheral vascular disease (PVD), Biomimetic stent, Helical centerline
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

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

  • Femoropopliteal stentingDevice

Study groups in NCT02163863
Study groupRoleWhat they receive
BioMimics 3DExperimentalThe BioMimics 3D Stent System, delivering a self-expanding Nitinol stent with 3D helical centerline geometry.
Receives: Device: Femoropopliteal stenting
ControlActive comparatorCR Bard LifeStent System, delivering a self-expanding Nitinol stent
Receives: Device: Femoropopliteal stenting

What is being measured

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

  1. Primary safety endpoint

    Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)

    Measured: 30 days

  2. Primary performance endpoint

    Freedom from clinically driven TLR

    Measured: 6 months

Secondary outcomes (5)

  1. Acute procedural outcomes

    • Device deployment success
    • Acute procedural success
    • Procedural complications

    Measured: Within 30 days of the procedure

  2. Post implant anatomical outcomes

    • Stented vessel geometry, i.e. presence/absence of 3D helical geometry in the stented region

    Measured: Immediately post implant but within the index procedure

  3. Mechanical outcomes

    • Stent integrity, i.e. presence/absence of kinks and fractures

    Measured: 30 days, 6, 12 and 24 months

  4. Haemodynamic outcomes

    • Restenosis measured by duplex ultrasound and angiography.
    • Swirling flow

    Measured: discharge, 30 days, 6, 12 and 24 months

  5. Clinical and functional outcomes

    • Rutherford classification (not at discharge)
    • ABI
    • Walking impairment questionnaire (not at discharge)
    • Freedom from major adverse events at 30 days, 6, 12 and 24 months.

    Measured: discharge, 30 days, 6, 12 and 24 months

Timeline

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

  1. First posted16 Jun 2014 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2012
  4. Study completionJul 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163863
Sponsor's protocol ID
Mimics
Acronym
Mimics
Status last verified
Nov 2019
First submitted
9 Jun 2014
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Zeller T, Gaines PA, Ansel GM, Caro CG. Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial. Circ Cardiovasc Interv. 2016 Jun;9(6):e002930. doi: 10.1161/CIRCINTERVENTIONS.115.002930.

    PubMed 27208046

Questions about this trial

What is this clinical trial studying?

A study testing Femoropopliteal stenting in people with Peripheral Arterial Disease, run by Veryan Medical Ltd. 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 9 inclusion and 22 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 14 Nov 2019. 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?

Primary safety endpoint (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT02163863, 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 14 Nov 2019.

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