The Biomimetic Stent and Vascular Functions Study
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Bio-MIMICS 3D StentDevice: Innova Stent
- Registration Number
- NCT05447052
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bio-MIMICS Stent Bio-MIMICS 3D Stent Helical shaped BioMimics 3D Stent Innova Stent Innova Stent Conventional: Nitinol Stent
- Primary Outcome Measures
Name Time Method Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure 12 months FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
- Secondary Outcome Measures
Name Time Method Changes in augmentation index Baseline, followed at 1 and 12 months Changes in cardiovascular function measured by augmentation index in %
Changes in pulse wave velocity Baseline, followed at 1 and 12 months Changes in cardiovascular function measured by pulse wave velocity in m/s
Changes in vascular strain Baseline, followed at 1 and 12 months Changes in cardiovascular function measured by vascular strain in %
Changes in clinical symptoms Baseline, followed at 1 and 12 months Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)
Number of participants with treatment-related adverse events Baseline, followed at 1 and 12 months Number of participants with treatment-related adverse events as assessed by SDWS
Changes of inflammatory profile measured by hs-CRP in mg/dl Baseline, followed at 1 and 12 months Blood samples are collected at the below mentioned time points
Primary patency (PP) of target lesion Baseline, followed at 1 and 12 months Primary patency determined by PVR measurement with ultrasound
Freedom from Target Lesion Revascularization Baseline, followed at 1 and 12 months Freedom from Target Lesion Revascularization (FTLR)
Changes in peripheral perfusion determined by ABI (ankle brachial index) Baseline, followed at 1 and 12 months 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
Changes in six-minute walk test Baseline, followed at 1 and 12 months Six-minute walk test determined by pain-free walking distance in m
Changes of inflammatory profile measured by oxLDL in µg/l Baseline, followed at 1 and 12 months Blood samples are collected at the below mentioned time points
Changes of inflammatory profile measured by Interleukin-6 in pg/ml Baseline, followed at 1 and 12 months Blood samples are collected at the below mentioned time points
Trial Locations
- Locations (1)
University of Essen, Clinic of Cardiology and Angiology
🇩🇪Essen, NRW, Germany