JPRN-jRCTs052200044招募中未知
A Prospective, Multicenter, Randomized Trial of New Cutting Balloon Versus Conventional Balloon for the Treatment of Severe Calcified Lesion - PREDICTION study
Koyama Kohei0 个研究点目标入组 170 人开始时间: 2020年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 170
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Among patients with ischemic heart disease scheduled to receive coronary artery intervention for heavily calcified lesion found on coronary angiography conducted before inclusion in this trial, those who meet all of the following inclusion criteria and none of the exclusion criteria are considered to be eligible:
- •1) Patients who gave written consent to participate in the study; and
- •2) Patients aged 20 years or older when giving informed consent.
排除标准
- •1) Patients with any of the following:
- •i) Lesion in the left main trunk;
- •ii) ST-elevation acute myocardial infarction (within 24 hours from onset);
- •iii) Lesion in bypass graft;
- •iv) In-stent restenotic lesion;
- •v) Chronic total occlusion lesion;
- •vi) Cardiogenic shock (systolic blood pressure < 90 mmHg sustained for 10 minutes or longer with no support, e.g. intra-aortic balloon pumping);
- •vii) Acute-phase cardiac failure;
- •viii) Sustained ventricular arrhythmia;
- •ix) Ejection Fraction < 30%;
- •x) Severe valvular disease; or
- •xi) Severe renal impairment (eGFR < 30mL/min/1.72m2, under non-dialysis).
- •2) Pregnant or lactating women
- •3) Patients with a history of hypersensitivity to contrast medium
- •4) Patients with a life expectancy of less than one year
- •5) Other patients determined to be ineligible for inclusion in the trial by the principal investigators.
研究者
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