Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of stent strut malapposition
研究概览
简要总结
The purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease.
详细描述
The development of coronary stents has significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) compared to balloon angioplasty alone. Nevertheless, restenosis is still encountered in 20 to 40% of coronary lesions after implantation of bare metal stents, inferring frequent repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents (DES), with their controlled release of therapeutic agents, have significantly reduced the rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound (IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of light in a technique similar to conventional ultrasound. With this technique a resolution up to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS. Optical coherence tomography has been used in vivo and has detected early atherosclerotic plaques previously not visualised by IVUS. Segments with strut malapposition and the presence or thickness of neointimal hyperplasia can also be more accurately assessed with OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a stainless steel stent. This stent will be compared in a randomized fashion to the permanent polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction
- •Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents
- •No limitation to the number of treated lesions, number of vessels or lesion length according to the randomization group
排除标准
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus, everolimus, contrast material
- •Acute ST-segment elevation myocardial infarction
- •Bypass graft
- •Inability to provide informed consent
- •Pregnancy
- •Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- •Left ventricular ejection fraction < 25%
- •Serum creatinine > 180mmol/L
结局指标
主要结局
Rate of stent strut malapposition
时间窗: 0 Days
Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment
Rate of stent strut tissue coverage
时间窗: At follow-up (one of either 3, 6, 12 or 15 months)
Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).
次要结局
- Major Adverse Cardiac Events(15 months)
研究者
Dr Peter Barlis
Associate Professor of Medicine, Principal Investigator
Northern Hospital, Australia