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

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.
 
ClinicalTrials.gov Identifier: NCT02163863
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Veryan Medical Ltd.

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date November 14, 2019
Study Start Date  ICMJE February 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Primary safety endpoint [ Time Frame: 30 days ]
    Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)
  • Primary performance endpoint [ Time Frame: 6 months ]
    Freedom from clinically driven TLR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Acute procedural outcomes [ Time Frame: Within 30 days of the procedure ]
    • Device deployment success
    • Acute procedural success
    • Procedural complications
  • 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
  • Mechanical outcomes [ Time Frame: 30 days, 6, 12 and 24 months ]
    - Stent integrity, i.e. presence/absence of kinks and fractures
  • Haemodynamic outcomes [ Time Frame: discharge, 30 days, 6, 12 and 24 months ]
    • Restenosis measured by duplex ultrasound and angiography.
    • Swirling flow
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BioMimics 3D Stent Clinical Investigation: The Mimics Study
Official Title  ICMJE BioMimics 3D Stent Clinical Investigation: The Mimics Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Device: Femoropopliteal stenting
Study Arms  ICMJE
  • Experimental: BioMimics 3D
    The BioMimics 3D Stent System, delivering a self-expanding Nitinol stent with 3D helical centerline geometry.
    Intervention: Device: Femoropopliteal stenting
  • Active Comparator: Control
    CR Bard LifeStent System, delivering a self-expanding Nitinol stent
    Intervention: Device: Femoropopliteal stenting
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). pii: e002930. doi: 10.1161/CIRCINTERVENTIONS.115.002930.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2014)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163863
Other Study ID Numbers  ICMJE Mimics
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Veryan Medical Ltd.
Study Sponsor  ICMJE Veryan Medical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Veryan Medical Ltd.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP