jRCT2080224719已完成3 期
Multicenter trial of new coronary artery stenosis with Paclitaxel coated balloon catheter
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Single-arm study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Clinical inclusion criteria
- •Patient with stable or unstable angina pectoris or documented silent ischemia
- •Patient is eligible for percutaneous coronary intervention
- •Patient is acceptable candidate for CABG
- •Angiographic inclusion criteria (by visual estimation)
- •Native coronary artery
- •The lesions in the main coronary artery or in a branch of it
- •De novo lesion
- •Stenotic lesion
- •The stenosis of target lesion is 50% or more to less than 100%
- •Target vessel diameter is 3.00 mm to 4.25 mm
- •Lesion length is 32 mm or less
排除标准
- •Clinical exclusion criteria
- •Patients who have serious illness and may not be able to follow up as defined in the protocol
- •Patients who have a history of allergy or contraindications to Paclitaxel and the raw materials for clinical trial equipment (polyamide and Iopromide)
- •Not a suitable candidate for DAPT
- •Known allergy to contrast media
- •Low cardiac function or suspected, LVEF less than 30%
- •Patients with hepatitis or cirrhosis or their suspicion
- •Renal dialysis or with renal dysfunction (Cre > 2.0 mg / dL)
- •Patients with active peptic ulcer or gastrointestinal bleeding
- •Patients with a history of coronary artery spasm
- •Cerebral infarction or transient ischemic attack within 3 months before the clinical trial procedure
- •AMI within 72 hours before the clinical trial procedure
- •PCI within 24 hours before the clinical trial procedure
- •Patients who are planning to PCI or CABG within 3 months after the clinical trial procedure
- •Patients scheduled for invasive or surgical procedure that must be discontinued for DAPT drugs in 3 months after the clinical trial procedure
- •Pregnant or may be pregnant
- •Currently participating in an investigational drug or device study
- •In cases where the Investigator determines that the patient's participation in the trial is inappropriate
- •Angiographic exclusion criteria
- •Within 9 months after implementing PCI on the target vessel
- •A vessel where there is an untreated intravascular thrombus
- •Treat with a high-speed rotational coronary atherectomy device, laser catheter for angioplasty, absorbable coronary stents, or devices that are not approved for use during a clinical trial procedure.
- •Lesion in left main coronary trunk
- •Lesion within 3 mm from the ostium right coronary artery
- •Lesion within 2 mm from the ostium left anterior descending/the ostium left circumflex branch
- •A lesion that needs to be treated using a PTCA balloon catheter with a special function in the balloon before using the trial device
- •Total occlusion
- •A lesion in which a stent has been placed within 5 mm proximal or distal in the past
结局指标
主要结局
-
safety efficacy confirmatory TLF incidence rate for 9 months after the trial procedure
次要结局
未报告次要终点
研究者
研究点 (1)
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