DCB in de Novo Coronary Lesion

赞助:

合作者:

信息的提供 (责任方):

Liu Bin，Second Hospital of Jilin University

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

December 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Lumen loss in advanced stage of lesion segments within 3 months[ Time Frame: 3 months ]

Lumen loss in advanced stage of lesion segments within 3 months

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate)[ Time Frame: 3 months ]
Occurrence rate of dissection after procedure[ Time Frame: 3 months ]
Binary restenosis rate 3 months after procedure[ Time Frame: 3 months ]
Cardiovascular clinical composite endpoints related to device at the time of 30 days, 60 days and 90days after the surgery include cardiac death, target vessel myocardial infarction and target lesion revascularization driven by clinical symptoms,[ Time Frame: 3 months ]
Cardiovascular clinical composite endpoints related to patients at the time of 30 days, 60 days and 90 days after the surgery include all-cause mortality, all myocardial infarction and any revascularization[ Time Frame: 3 months ]
ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage)[ Time Frame: 3 months ]

描述性信息

简略标题 ^ICMJE

DCB in de Novo Coronary Lesion

正式标题 ^ICMJE

Prospective Clinical Research on Safety and Efficacy of Drug Coated Balloon in de Novo Coronary Lesion With Diameters Larger Than 2.75 mm Under OCT Guidance

简要概况

Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic recoil and dissection are easier to appear upon dilatation, which will result in acute vascular occlusion and restenosis, so it is not recommended for great vessels to only receive PTCA therapy. But for patients with good angiography result without combination of serious dissections after predilation, the acute thrombosis seems to be a key factor for acute vascular occlusion. Traditional antiplatelet drug doesn't have a good effect, but the application of new-generation antiplatelet drug (clopidogrel, ticagrelor and tirofiban) has greatly reduced the occurrence rate of acute thrombosis. Therefore, under the guarantee of fully antiplatelet action of new-generation antiplatelet drug, for the patients with good angiography result without combination of serious dissections after predilation, Drug coated balloon seems to be an alternative of the stent. This research is to verify the safety and efficacy of Drug coated balloon in de novo coronary artery lesion with vascular diameter ≥2.75mm.

详细说明

Stable or unstable angina patients who accept drug coated balloon dilatation therapy with diameter stenosis≥50%, reference diameter≥2.75mm will be enrolled. OCT examination should be carried out after radiography, predilation, Drug coated balloon dilatation and follow-up. For target lesion, balloon should be used for predilation (the ratio of balloon diameter to vascular diameter being 0.8-1.0:1), and for good predilation effects, high pressure balloon, cutting balloon, dual-wire balloon and spines balloon can be adopted. OCT examination should be carry out after balloon satisfactory predilation. Satisfactory predilation radiography result is residual stenosis≤30%,TIMI 3 flow without major dissections (type C or higher) in NHLBI classification. OCT satisfactory result is residual stenosis≤30% without dissection, or with dissection but the dissection angle is ≤90°. Then carry out DCB balloon dilatation therapy. The ratio of balloon diameter to vascular diameter is 0.8-1.0:1, and both ends of DCB exceed the preprocessing area of lesion for 2-3mm, thus avoiding the occurrence of geographical mismatch. Dilation pressure is 8-10atm, lasting for at least 30s. Each DCB catheter can be used once only.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述: Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: Drug coated balloon
Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy

研究工具

Experimental: Drug coated balloon
Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 2019

预计主要完成日期

December 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria - At the age of 18-80 (18 and 80 included) - The female at reproductive age shouldn't get pregnant or plan to get pregnant during the research - Patients must agree to accept 3-month angiography follow-up - Patients must agree to accept clinical follow-up on 30-day, 60-day and 90-day after operation - Psychologically and linguistically, patients could have an understanding of the research purpose, revealing sufficient compliance with the research proposal. The patients' provision of the informed consent represents that the patient accepts the risks and benefits described in the informed consent. - Target lesion diameter stenosis is ≥50%, and reference vascular diameter is ≥2.75mm - De novo coronary lesion - Type A lesion Exclusion criteria - Patients with myocardial infarction within one week - Patients with congestive heart failure or severe NYHAIV heart failure - Patients with severe valvular heart disease - The female in pregnancy or lactation period - Patients whose life expectancy don't exceed 1 year or who might have difficulty in clinical follow-up - Patients who are of bleeding physique or forbidden to administer anticoagulants or antiplatelet drugs - Patients who suffered from cerebral stroke within 6 months prior to surgery - Patients who are involved in any other clinical trials - Patients who fail to satisfy angiography conditions due to currently suffering from or previously undergoing severe renal failure (GFR<30ml/min) - Patients who underwent heart transplantation - Patients who are deemed inappropriate for inclusion by the researcher due to other reasons - Lesion of left main coronary artery - Double vessel or triple vessel disease needed to be interventional treated - Double vessel or triple vessel disease needed to be interventional treated - Patients who are intolerant of aspirin and/or clopidogrel, have the medical history of neutrocytopenia or thrombocytopenia, or are forbidden to administer clopidogrel due to severe hepatic insufficiency - Patients with known hypersensitivity - Patients with the history of leukopenia (white blood cell count<3x109/L for over 3 days), or neutrocytopenia (ANCs <1,000 neutrophils/mm3 for over 3 days) or thrombocytopenia (blood platelets<100,000/mm3) - Patients having the history of peptic ulcer or gastrointestinal bleeding within the past 6 months

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：80 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Liu Bin，Second Hospital of Jilin University

研究赞助商 ^ICMJE

Second Hospital of Jilin University

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Bin Liu, Doctor Second Hospital of Jilin University

PRS 账户

Second Hospital of Jilin University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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