jRCT1030240071招募中不适用
JDEPTH-LM Registry: Japanese Coronary Intervention using Drug Eluting and Perfusion Therapy for Left Main Disease
N/A0 个研究点目标入组 280 人开始时间: 2024年5月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 主要终点
- Procedure success rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age >= 18 years
- •Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
- •Left main disease confirmed by coronary angiography or coronary CT angiography
- •Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
- •Patient with consent prior to undergoing PCI
- •Left main Medina classification (1,1,1), (1,0,1), (0,1,1) and (0,0,1) confirmed by coronary angiography
- •De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
- •De novo ostial LCx lesions
- •Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography
排除标准
- •Inability to provide written informed consent
- •Patient with a history of ST-elevation myocardial infarction within the previous 1 week
- •Patient in a state of cardiogenic shock
- •Patient with a history of coronary artery bypass grafting
- •Patient with malignant tumors or other conditions with a life expectancy of less than one year
- •Patient considered suitable for stent placement in the ostial LCx from a medical perspective
- •Patient considered unsuitable for anti-thrombotic therapy after PCI
- •Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
结局指标
主要结局
Procedure success rate
indicating the proportion of cases meeting the following three conditions: - Device delivery success - Achievement of DCB expansion for 30 seconds or more - No bailout stenting performed in the LCx
MACE at 12 months
时间窗: 12 months
consisting of all-cause mortality, nonfatal MI, and ischemia-driven unplanned revascularization for left main disease
次要结局
- Time to ST-change from DCB inflation
- Total DCB Inflation time
- Maximum changes in blood pressure and heart rate
- Use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT(after W-KBT)
- Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
研究者
相似试验
招募中
不适用
Japanese Lead Extraction (J-LEX) RegistryArrhythmias requiring cardiovascular implantable electronic devicesJPRN-UMIN000036078ational Cerebral and Cardiovascular Center5,000
已完成
不适用
Japanese multicenter REsearch of COVID-19 by assEmbling Real-world dataCOVID-19JPRN-UMIN000047056ippon Medical School Musashikosugi Hospital4,700
尚未招募
不适用
Dutch Critical Limb Ischemia RegistryNL-OMON25441one1,000
招募中
不适用
MENINT-Register - Prospective register of patients with bacterial meningitis at intensive care units in GermanyG00Bacterial meningitis, not elsewhere classifiedDRKS00017576eurologische Klinik und Poliklinik, Klinikum der LMU München - Großhadern250
已完成
不适用
Reveal LINQ Registrynexplained syncope Cryptogenic SrokeJPRN-UMIN000023158Medtronic Japana Co., Ltd1,614