Comparison of the Everolimus Eluting (XIENCE-V® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study The COMPARE II Trial Imaging and Vasomotion Substudy
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- percentage of uncovered stent struts per lesion assessed by OCT
研究概览
简要总结
The purpose of the study is to compare strut coverage and neointimal thickness between everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation and to determine the coronary endothelial function after everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14 months after stent implantation by using supine bicycle exercise testing to assess coronary vasomotor response to exercise.
详细描述
DESIGN:
Imaging and vasomotion Substudy:
50 consecutive patients enrolled in the COMPARE II trial at the University of Fribourg Medical Center will undergo follow-up re-angiography 14 months after index procedure with assessment of Optical coherence tomography (OCT) and vasomotion testing.
ENDPOINT SUBSTUDY (all at 14 months):
Primary endpoint imaging: percentage of uncovered stent struts per lesion and mean neointimal thickness assessed by OCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled in the COMPARE II trial with successful stent implantation and absence of binary restenosis or severe progression of coronary artery disease at 14 months follow-up.
- •Patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing
排除标准
- •Inability to provide informed consent
- •Inability to perform a supine bicycle exercise stress test
- •Binary in stent restenosis of the target vessel
- •Acute Coronary Syndrome, Acute Myocardial Infarction
- •Patients with stent thrombosis following the index procedure
- •Female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy
- •Known intolerance to heparin, contrast material
- •History of bleeding diathesis or known coagulopathy
- •Age ≥ 80 years
- •Hemodynamic instability
- •Renal failure (creatinine clearance ≤ 40 ml/min)
- •OCT / IVUS technically not feasible
研究组 & 干预措施
dynamic physical exercise OCT
dynamic physical exercise and optical coherence tomography imaging
干预措施: dynamic physical exercise and OCT imaging (Other)
结局指标
主要结局
percentage of uncovered stent struts per lesion assessed by OCT
时间窗: within 14 months after percutaneous coronary stent implantation
次要结局
- coronary vasomotor function(within 14 months after stentimplantation)
- mean neointimal thickness assessed by OCT(within 14 months after stent implantation)