NCT00857441已完成2 期
A Prospective Three-arm Multi-center Study to Investigate Procedural, Clinical and Angiographic Outcomes Using a Drug Eluting Balloon Versus a Standard Balloon in Combination With a Bare Metal Stent and a DES Stent, Following the Provisional Side Branch T-stenting Approach, in Patients With Complex Lesions
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
研究概览
简要总结
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:
- Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
- Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.
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
- •Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
- •Patients eligible for coronary revascularisation
- •The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm)
- •Patient must be acceptable for CABG
- •De novo lesion
- •The main vessel lesion can be covered by one stent (up to 32mm)
- •Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG)
- •Signed patients informed consent
排除标准
- •Patient unable to give informed consent
- •Patients with a previous PCI in the target vessel
- •Patients with in stent restenosis of target lesion
- •Left ventricular ejection fraction more than 30%
- •Patients with left main disease
- •Severe calcifications with an undilatable lesion during balloon predilatation
- •History of bleeding diathesis
- •Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention.
- •Patient has suffered a stroke or TIA within the past 3 months
- •Life expectancy < 1 year
- •Any major surgery planned or required during the next 6 months
- •Acute Myocardial Infarction
- •Only one target lesion can be included in the study
- •Allergy to contrast and/or required anti-platelet medication
- •Patients unwilling to return for follow-up at 6 months
研究组 & 干预措施
1
Experimental
Use of Dior balloon and implant of Liberté Bare Metal Stent
干预措施: Drug eluting balloon (Device)
1
Experimental
Use of Dior balloon and implant of Liberté Bare Metal Stent
干预措施: Liberté (Device)
2
Active Comparator
Use of standard balloon and implant of Liberté Bare Metal Stent
干预措施: Liberté (Device)
2
Active Comparator
Use of standard balloon and implant of Liberté Bare Metal Stent
干预措施: PTCA balloon catheter (Device)
3
Active Comparator
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
干预措施: PTCA balloon catheter (Device)
3
Active Comparator
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
干预措施: Taxus (Device)
结局指标
主要结局
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
时间窗: 6 months
次要结局
- Major Angiographic coronary or cerebral Events (MACCE)(6 months)
- Target vessel failure (TVF)(6 months)
研究者
研究点 (3)
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