The Biomimetic Stent and Vascular Functions Study

Study Overview
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Brief Summary
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The aim of this IIT is to determine the potential improvement and impact of the BioMimics 3D Stent System in the SFA on local vascular function.

Detailed Description
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The MIMICS FLOW Study is a single-center, single-blind, investigator-initiated, randomized parallel group trial. The impact of a novel biomimetical stent with a helical curvature provides superior hemodynamic and biomechanical performance and advantages. Additionally, it promotes swirling blood flow, elevating wall sheer strength, which is patency-protective and might impact on vascular functions due to completely different vascular properties through altered blood flow. The influence of the novel devices and stent-platforms with improved hemodynamic capabilities with respect to vasomotor of the vessel wall, vascular function and vascular compliance can be measured by FMD, arterial stiffness indices and vascular strain analysis.

Official Title
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The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Bio-MIMICS 3D Stent
* Device: Innova Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peripheral artery disease Target lesions in the proximal (3 cm distal to the CFA-bifurcation) middle and distal SFA Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2,3,4 Planed peripheral intervention TASC A-D Subject must be between 18 and 85 years old Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation Vessel diameter >/= 4.0 mm and </=7.0 mm Target lesion length < 140 mm (segment to be stented) Willing to comply with the specified follow-up evaluation Written informed consent prior to any study procedures Pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter) usage of Biomimics stent as described in the IFU, especially regarding stent diameters and vessel size Exclusion Criteria: Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement Requiring stent implantation in the PA Instent-Restenosis Thrombolysis within 72 Hours prior to the index procedure Aneurysm formations in the femoral artery or popliteal artery Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy Unstable angina pectoris at the time of the enrollment Recent myocardial infarction or stroke <30 days prior to the index procedure Life expectancy less than 12 months Septicaemia at the time of enrollment Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-MIMICS Stent<br>Helical shaped BioMimics 3D Stent | Device: Bio-MIMICS 3D Stent<br>* Bio-MIMICS Stent implantation<br>|
| Active Comparator: Innova Stent<br>Conventional: Nitinol Stent | Device: Innova Stent<br>* Innova Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure | FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery. | 1 month | 
| Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure | FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pulse wave velocity | Changes in cardiovascular function measured by pulse wave velocity in m/s | Baseline, followed at 1 and 12 months | 
| Changes in augmentation index | Changes in cardiovascular function measured by augmentation index in % | Baseline, followed at 1 and 12 months | 
| Changes in vascular strain | Changes in cardiovascular function measured by vascular strain in % | Baseline, followed at 1 and 12 months | 
| Changes in peripheral perfusion determined by ABI (ankle brachial index) | ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure | Baseline, followed at 1 and 12 months | 
| Primary patency (PP) of target lesion | Primary patency determined by PVR measurement with ultrasound | Baseline, followed at 1 and 12 months | 
| Changes in clinical symptoms | Clinical symptoms of patients determined by Walking impairment questionaire (WIQ) | Baseline, followed at 1 and 12 months | 
| Changes in six-minute walk test | Six-minute walk test determined by pain-free walking distance in m | Baseline, followed at 1 and 12 months | 
| Freedom from Target Lesion Revascularization | Freedom from Target Lesion Revascularization (FTLR) | Baseline, followed at 1 and 12 months | 
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by SDWS | Baseline, followed at 1 and 12 months | 
| Changes of inflammatory profile measured by hs-CRP in mg/dl | Blood samples are collected at the below mentioned time points | Baseline, followed at 1 and 12 months | 
| Changes of inflammatory profile measured by oxLDL in µg/l | Blood samples are collected at the below mentioned time points | Baseline, followed at 1 and 12 months | 
| Changes of inflammatory profile measured by Interleukin-6 in pg/ml | Blood samples are collected at the below mentioned time points | Baseline, followed at 1 and 12 months |