The Biomimetic Stent and Vascular Functions Study

University Hospital Essen

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Bio-MIMICS 3D Stent; Device: Innova Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05447052

The MIMICS FLOW STUDY

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Bio-MIMICS Stent

Experimental group

Description:

Helical shaped BioMimics 3D Stent

Treatment:

Device: Bio-MIMICS 3D Stent

Innova Stent

Active Comparator group

Description:

Conventional: Nitinol Stent

Treatment:

Device: Innova Stent