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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Bio-MIMICS Stent implantation
Innova Stent implantation
University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, Germany
RECRUITINGChange 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.
Time frame: 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.
Time frame: 12 months
Changes in pulse wave velocity
Changes in cardiovascular function measured by pulse wave velocity in m/s
Time frame: Baseline, followed at 1 and 12 months
Changes in augmentation index
Changes in cardiovascular function measured by augmentation index in %
Time frame: Baseline, followed at 1 and 12 months
Changes in vascular strain
Changes in cardiovascular function measured by vascular strain in %
Time frame: 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
Time frame: Baseline, followed at 1 and 12 months
Primary patency (PP) of target lesion
Primary patency determined by PVR measurement with ultrasound
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, followed at 1 and 12 months
Changes in clinical symptoms
Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)
Time frame: 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
Time frame: Baseline, followed at 1 and 12 months
Freedom from Target Lesion Revascularization
Freedom from Target Lesion Revascularization (FTLR)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, followed at 1 and 12 months