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BioMimics 3D Stent Clinical Investigation: The Mimics Study (Mimics)

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ClinicalTrials.gov Identifier: NCT02163863
Recruitment Status : Unknown
Verified June 2014 by Veryan Medical Ltd..
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Veryan Medical Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Femoropopliteal stenting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BioMimics 3D Stent Clinical Investigation: The Mimics Study
Study Start Date : February 2010
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioMimics 3D
The BioMimics 3D Stent System, delivering a self-expanding Nitinol stent with 3D helical centerline geometry.
Device: Femoropopliteal stenting
Active Comparator: Control
CR Bard LifeStent System, delivering a self-expanding Nitinol stent
Device: Femoropopliteal stenting



Primary Outcome Measures :
  1. Primary safety endpoint [ Time Frame: 30 days ]
    Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)

  2. Primary performance endpoint [ Time Frame: 6 months ]
    Freedom from clinically driven TLR


Secondary Outcome Measures :
  1. Acute procedural outcomes [ Time Frame: Within 30 days of the procedure ]
    • Device deployment success
    • Acute procedural success
    • Procedural complications

  2. Post implant anatomical outcomes [ Time Frame: Immediately post implant but within the index procedure ]
    - Stented vessel geometry, i.e. presence/absence of 3D helical geometry in the stented region

  3. Mechanical outcomes [ Time Frame: 30 days, 6, 12 and 24 months ]
    - Stent integrity, i.e. presence/absence of kinks and fractures

  4. Haemodynamic outcomes [ Time Frame: discharge, 30 days, 6, 12 and 24 months ]
    • Restenosis measured by duplex ultrasound and angiography.
    • Swirling flow

  5. Clinical and functional outcomes [ Time Frame: discharge, 30 days, 6, 12 and 24 months ]
    • 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >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
  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT02163863


Sponsors and Collaborators
Veryan Medical Ltd.
Investigators
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Principal Investigator: Thomas Zeller, M.D. Universitäts-Herzzentrum Freiburg Bad Krozingen
Principal Investigator: Sebastian Sixt, MD Medizinisches Versorgungszentrum Hamburg
Principal Investigator: Henrik Schroeder, MD Zentrum für Minimal Invasive Therapie Berlin
Principal Investigator: Horst Sievert, MD Cardiovascular Center Frankfurt
Principal Investigator: Karl-Ludwig Schulte, MD Königin Elisabeth Herzberge Berlin
Principal Investigator: Gunnar Tepe, MD Klinikum Rosenheim
Principal Investigator: Giovanni Torsello, MD St. Franziskus-Hospital Münster
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Leipzig

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Veryan Medical Ltd.
ClinicalTrials.gov Identifier: NCT02163863     History of Changes
Other Study ID Numbers: Mimics
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

Keywords provided by Veryan Medical Ltd.:
Peripheral arterial disease (PAD)
Peripheral vascular disease (PVD)
Biomimetic stent
Helical centerline

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