The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
时间窗: 12 months
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
次要结局
- Changes in augmentation index(Baseline, followed at 1 and 12 months)
- Changes in pulse wave velocity(Baseline, followed at 1 and 12 months)
- Changes in vascular strain(Baseline, followed at 1 and 12 months)
- Changes in clinical symptoms(Baseline, followed at 1 and 12 months)
- Number of participants with treatment-related adverse events(Baseline, followed at 1 and 12 months)
- Changes of inflammatory profile measured by hs-CRP in mg/dl(Baseline, followed at 1 and 12 months)
- Primary patency (PP) of target lesion(Baseline, followed at 1 and 12 months)
- Freedom from Target Lesion Revascularization(Baseline, followed at 1 and 12 months)
- Changes in peripheral perfusion determined by ABI (ankle brachial index)(Baseline, followed at 1 and 12 months)
- Changes in six-minute walk test(Baseline, followed at 1 and 12 months)
- Changes of inflammatory profile measured by oxLDL in µg/l(Baseline, followed at 1 and 12 months)
- Changes of inflammatory profile measured by Interleukin-6 in pg/ml(Baseline, followed at 1 and 12 months)
研究者
Chistos Rammos
Prof. Dr. med. C. Rammos, MD, FESC, MHBA
University Hospital, Essen