BioMimics 3D Stent Clinical Investigation: The Mimics Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Veryan Medical Ltd.
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Primary safety endpoint
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Acute procedural outcomes(Within 30 days of the procedure)
- Post implant anatomical outcomes(Immediately post implant but within the index procedure)
- Mechanical outcomes(30 days, 6, 12 and 24 months)
- Haemodynamic outcomes(discharge, 30 days, 6, 12 and 24 months)
- Clinical and functional outcomes(discharge, 30 days, 6, 12 and 24 months)