NL-OMON22515尚未招募不适用
Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels
Fondazione Ricerca e Innovazione Cardiovascolare ETS0 个研究点目标入组 1,130 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •age >18 years;
- •- all patients with a clinical indication to PCI (stable coronary artery disease or acute coronary syndromes);
- •- native coronary artery lesion in a vessel with diameter >2.0 mm and ?3.0 mm at visual estimation;
- •- maximum lesion lenght: 40 mm.
- •- informed consent to participate in the study.
排除标准
- •- patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
- •- patients participating in another clinical study;
- •- subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception);
- •- creatinine clearance <30 ml/min;
- •- left ventricular ejection fraction <30%;
- •- life expectancy <12 months;
- •- ST-elevation myocardial infarction in the previous 48 hours;
- •- visible thrombus at lesion site;
- •- culprit lesion stenosis >99% and/or TIMI flow <2;
- •- target lesion/vessel with any of the following characteristics:
- •- concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary
- •- pre-dilatation of the target lesion not performed or not successful (residual stenosis >30%);
- •- severe calcification of the target vessel, at lesion site but also proximally;
- •- highly tortuous vessel which could impair device delivery to the lesion site following Investigator’s judgement;
- •- previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery);
- •- bifurcation lesion where side branch treatment is anticipated;
- •- left main stem stenosis >50%;
- •- target lesion is in left main stem
研究者
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