BioMimics 3D Stent Clinical Investigation: The Mimics Study

Veryan Medical

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Femoropopliteal stenting

Study type

Interventional

Funder types

Industry

Identifiers

NCT02163863

Mimics

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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