NL-OMON54743招募中不适用
Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease - BioVasc Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 794
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years or minimum age as required by local regulations
- •2. The patient is an acceptable candidate for treatment with a drug eluting
- •stent in accordance with the applicable guidelines on percutaneous coronary
- •interventions, manufacturer*s Instructions for Use and the Declaration of
- •3. Patient indication, lesion length and vessel diameter of the target
- •lesion(s) are according to the *Instructions for Use* that comes with every
- •Biotronik Orsiro (Sirolimus-Eluting stent) system. Patients should qualify for
- •both systems before randomization
- •4. The patient is willing and able to cooperate with study procedures and
- •required follow up
- •5. The subject or legal representative has been informed of the nature of the
- •study and agrees to its provisions and has provided an EC approved written
- •informed consent, including data privacy authorization
- •6. diagnosed Acute coronary syndrome according to ESC guidelines/criteria
- •7. Multivessel disease
排除标准
- •Age <18 years and > 85 years
- •Single coronary vessel disease
- •Patients in cardiogenic shock
- •Patients who cannot give informed consent or have a life expectancy of less
- •Absolute contraindications or allergy that cannot be pre-medicated, to
- •iodinated contrast or to any of the study medications, including both aspirin
- •and P2Y12 inhibitors.
- •Enrollment in another study with another investigational device or drug trial
- •that has not reached the primary endpoint The patient may only be enrolled
- •once in the BioVAsc study
- •PCI in the previous 30 days.
- •Presence of a chronic total occlusion
- •Women of childbearing potential who do not have a negative pregnancy test
- •within 7 days before the procedure and women who are breastfeeding.
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy is
- •maintained throughout the peri-surgical period
研究者
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