Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-MIMICS Stent | Experimental | Helical shaped BioMimics 3D Stent |
|
| Innova Stent | Active Comparator | Conventional: Nitinol Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-MIMICS 3D Stent | Device | Bio-MIMICS Stent implantation |
| |
| 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 |
| 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 % |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christos Rammos, Professor | Contact | 0201-723-84808 | christos.rammos@uk-essen.de | |
| Tienush Rassaf, Professor | Contact | 0201-723-4801 | tienush.rassaf@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Christos Rammos, Professor | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Essen, Clinic of Cardiology and Angiology | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Innova Stent |
| Device |
Innova Stent implantation |
|
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |