Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- • Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation
研究概览
简要总结
The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.
Hypotheses:
- The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.
- Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (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 4.25 mm which can be covered with one or multiple stents
- •No limitation to the number of treated lesions or number of vessels according to the randomization group
- •De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length
排除标准
- •Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
- •Acute ST-segment elevation myocardial infarction
- •Type A lesion including vessel angulation <45 degrees
- •Bypass graft
- •Inability to provide informed consent
- •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
研究组 & 干预措施
Platinum Chromium Everolimus-eluting stent (Promus Element)
Platinum Chromium Everolimus-eluting stent (Promus Element)
干预措施: Everolimus eluting stents (Device)
Cobalt Chromium Everolimus-eluting stent (Xience Prime)
Cobalt Chromium Everolimus-eluting stent (Xience Prime)
干预措施: Everolimus eluting stents (Device)
结局指标
主要结局
• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation
时间窗: Immediately following stent deployment
次要结局
- Mean neointimal tissue thickness (microns)(6 months post initial PCI Procedure)
- Percentage of uncovered stent struts(6 mths post initial PCI procedure)
- Stent length (mm) measured using OCT(6 months post initial PCI procedure)
研究者
A/Prof. Peter Barlis
Interventional Cardiologist
Northern Hospital, Australia