JPRN-UMIN000010164已完成4 期
A Prospective Multicenter Post-Approval Study to Evaluate the Long-Term Efficacy and Safety of the Resolute Integrity in the Japanese All-Comers Patients with Coronary Artery Disease - PROPEL STUDY
Associations for Establishment of Evidence in Interventions0 个研究点目标入组 1,200 人开始时间: 2013年3月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional,observational
入排标准
- 年龄范围
- 20years-old 至 85years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients aged 85 years or older. 2.Patients with cardiogenic shock. 3.Patients who are pregnant or possibly pregnant. 4.Patients who cannot comply with the antiplatelet therapy specified for this clinical study. 5.Patients scheduled to undergo elective surgery within 6 months post-index PCI. 6.Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives. 7.Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given. 8.Patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., BioLinx) contained in the materials of the study device or in whom these substances are specifically contraindicated. 9.Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.
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