NCT01060306撤回不适用
Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent
Ospedale Santa Maria Goretti1 个研究点 分布在 1 个国家开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation
研究概览
简要总结
PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >50 years
- •de novo lesion
- •lesion length <24 mm
- •reference vessel diameter 3 mm
排除标准
- •low compliance to dual antiplatelet therapy
- •life expectancy <1 year
- •allergy to any drug or substance use prior, during or after percutaneous coronary intervention
- •chronic renal insufficiency
- •low left ventricle ejection fraction (<35%)
- •recent acute myocardial infarction
- •previous coronary intervention
- •off-label indication to stenting
- •participation in another investigation
- •refusal to participate to the study
结局指标
主要结局
Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation
时间窗: 6 months
次要结局
- Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation(7 months)
- Comparison of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation and of its bare metal stent counterpart (Gazelle) one month after implantation(7 months)
- Comparison of the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months) and at one month after this time-point (7 months)(7 months)
研究者
Gregory Sgueglia, MD
MD, PhD
Ospedale Santa Maria Goretti
研究点 (1)
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