Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
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
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
详细描述
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis.
The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35)
The analysis of the primary end point will be performed on an intention-to-treat basis.
Subgroup analyses will be performed according to PAD classification etiology and based on stent length.
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
- None
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 3 cm distal to the CFA-bifurcation including SFA and PA lesions
- •Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- •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
- •Willing to comply with the specified follow-up evaluation
- •Written informed consent prior to any study procedures
- •Pretreatment with an adequately sized balloon
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
- •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
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 peripheral perfusion determined by ABI (ankle brachial index)(Baseline, followed at 1, 6 and 12 months)
- Changes in augmentation index(Baseline, followed at 1, 6 and 12 months)
- Changes in six-minute walk test(Baseline, followed at 1, 6 and 12 months)
- Procedural complications(Baseline, followed at 1, 6 and 12 months)
- Freedom from Target Lesion Revascularization(Baseline, followed at 1, 6 and 12 months)
- MALE(Baseline, followed at 1, 6 and 12 months)
- Changes in pulse wave velocity (PWV)(Baseline, followed at 1, 6 and 12 months)
- Changes in vascular strain(Baseline, followed at 1, 6 and 12 months)
- Primary patency (PP) of target lesion(Baseline, followed at 1, 6 and 12 months)
- Changes in clinical symptoms(Baseline, followed at 1, 6 and 12 months)
- Changes of inflammatory profile measured by hs-CRP in mg/dl(Baseline, followed at 1, 6 and 12 months)
- Changes of inflammatory profile measured by oxLDL in µg/l(Baseline, followed at 1, 6 and 12 months)
- Changes of inflammatory profile measured by Interleukin-6 in pg/ml(Baseline, followed at 1, 6 and 12 months)
研究者
Chistos Rammos
Prof. Dr. med. C. Rammos, MD, FESC, MHBA
University Hospital, Essen