NCT00936169已完成不适用
Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS0 个研究点目标入组 284 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 主要终点
- Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
研究概览
简要总结
The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion
排除标准
- •Contra-indication to dual anti-platelet therapy.
- •Ejection fraction <30%.
- •Renal failure (creatinine >2 mg/dL).
- •Significant co-morbidity precluding clinical follow-up.
- •Acute myocardial infarction in the 48 hours prior to the procedure.
- •In-stent restenosis
- •Prior brachytherapy
- •Thrombocytopenia <100,000
- •Unprotected left main stem stenosis
- •Venous or arterial grafts
- •Recipient of heart transplant
- •A positive pregnancy test in women with child bearing potential
- •Acute infections
- •Major surgery planned which will lead to discontinuation of antiplatelet therapy
- •Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
- •Age under 18 years old.
- •There is no maximum number of lesions which can be treated
结局指标
主要结局
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
时间窗: Procedure day
次要结局
- Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group(9 months)
- Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.(9 months)
- MACE events at 2 years.(2 years)
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