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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Femoropopliteal stenting

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: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany
    • Universitaets-Herzzentrum Freiburg-Bad Krozingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint	Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)	30 days
Primary performance endpoint	Freedom from clinically driven TLR	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural outcomes	Device deployment success; Acute procedural success; Procedural complications	Within 30 days of the procedure
Post implant anatomical outcomes	- Stented vessel geometry, i.e. presence/absence of 3D helical geometry in the stented region	Immediately post implant but within the index procedure
Mechanical outcomes	- Stent integrity, i.e. presence/absence of kinks and fractures	30 days, 6, 12 and 24 months
Haemodynamic outcomes	Restenosis measured by duplex ultrasound and angiography.; Swirling flow	discharge, 30 days, 6, 12 and 24 months
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.	discharge, 30 days, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Veryan Medical Ltd.
• Investigators: 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: Giovanni Torsello, MD, St. Franziskus Hospital Münster; Principal Investigator: Dierk Scheinert, MD, Park-Krankenhaus Leipzig

Publications and helpful links

General 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.

Helpful Links

• Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral arterial disease (PAD); Peripheral vascular disease (PVD); Biomimetic stent; Helical centerline
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Mimics