Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Apposition and neointimal coverage on the stent and scaffold strut
研究概览
简要总结
This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS
详细描述
All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 20 years old or older
- •Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
- •Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
- •Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
- •Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
- •Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure
排除标准
- •Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
- •Subject has known left ventricular ejection fraction (LVEF) < 30%
- •Subject is receiving hemodialysis
- •Target vessel were treated by PCI within 12 months
- •Target lesion is located within a saphenous vein graft or an arterial graft
- •Target lesion is located in ostium
- •Target lesion is located highly tortuous equal to or greater than 60 degrees
- •Target lesion with TIMI flow 0 (total occlusion)
研究组 & 干预措施
Coronary artery implanted with SYNERGY stent
One of the blocked coronary artery of a patient will received SYNERGY stent
干预措施: SYNERGY stent (Device)
Coronary artery implanted with ABSORB scaffold
Another blocked coronary artery of the same patient will received ABSORB scaffold
干预措施: BVS ABSORB scaffold (Device)
结局指标
主要结局
Apposition and neointimal coverage on the stent and scaffold strut
时间窗: 4 months
Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.
次要结局
- Apposition and neointimal coverage on the stent and scaffold strut(12 months)
研究者
Wan Azman Wan Ahmad
Professor Dr
University of Malaya