NCT02946307已完成不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Trial, Assessing the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease in Chinese Population With Coronary Heart Disease
ZhuHai Cardionovum Medical Device Co., Ltd.12 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- In-segment diameter stenosis(%).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Related to the patients:
- •Age ≥18 years old
- •Patients with stable or unstable angina pectoris, or recent myocardial infarction which has been stabilized (occurred over 7 days before enrollment, including non-st segment elevation myocardial infarction(NSTMI) and STMI), or proved asymptomatic regional myocardial ischemia
- •Patients in the small vessel cohort should be suitable for balloon dilation angioplasty or stent implantation, patients in the very small vessel cohort should be suitable for balloon dilation angioplasty.
- •Patients should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2, 3, 4, and
- •It is required to perform angiography in month-
- •Patients should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document.
- •Related to the diseases:
- •Patients with de novo, in situ lesions of small coronary vessels, the length of the lesion should be ≤26mm according to visual inspection. In the small vessel cohort, the diameter of the target lesion should be ≥2.25mm and ≤2.75mm according to visual inspection, and in the very small vessel cohort, the diameter of the target lesion should be ≥
- •00mm and <2.25mm according to visual inspection.
- •The diameter stenosis according to visual inspection before intervention treatment should be ≥70% or ≥50% with the evidence of ischemia.
- •Each patient is allowed to have only one lesion of the target small vessel (2 lesions with the distance ≤10mm and total length ≤26mm which could be treated with the same balloon or stent is considered as one lesion).
排除标准
- •Related to the patients:
- •Myocardial infarction occurred within 1 week before enrollment.
- •Patients with severe congestive heart failure or New York Heart Association (NYHA) grade IV heart failure
- •Left ventricular ejection fraction (LVEF) <35%
- •Patients who had heart transplantation
- •Patients with severe valvular heart disease
- •The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
- •Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
- •Patients with renal insufficiency (eGFR<30ml/min)
- •Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
- •Patients who are known to be allergic to Paclitaxel or Zotarolimus
- •The patients have a life expectancy of less than 1 year, or it would be difficult to finish follow-ups within 1 year.
- •Pregnant or lactating women, or female patients at a child-bearing age who plan to get pregnant during the period of the study or could not take effective contraceptives
- •The patients are participating in any clinical trials of other drugs or devices before reaching the primary endpoints.
- •Patients who are unsuitable for the study according to the investigator due to other reasons
- •Related to the diseases:
- •Patients with total occlusion of the target vessel
- •The patients have severe calcification of the target lesion, and therefore balloon pre-dilation could not be performed successfully.
- •The target lesions are bifurcation lesion with the diameter of the branch vessel >2.00mm.
- •The target lesions are in-stent restenosis.
- •Angiography indicates thrombosis in the target vessel.
- •Complicated with lesions in left main(LM) requiring intervention treatment
- •There are more than 2 non-target lesions which require treatment, or could not be treated with intervention before the target lesion, or the treatment had failed.
研究组 & 干预措施
small vessel cohort:Restore DEB
Experimental
receiving the treatment with Restore DEB（dimeter>2.00 mm） in small vessel cohort
干预措施: Restore DEB（dimeter>2.00 mm） (Device)
small vessel cohort:Resolute DES
Active Comparator
receiving the treatment with Resolute DES in small vessel cohort
干预措施: Resolute DES (Device)
very small vessel cohort:Restore DEB
Other
receiving the treatment with Restore DEB（dimeter:2.00 mm）in very small vessel cohort
干预措施: Restore DEB（dimeter:2.00 mm） (Device)
结局指标
主要结局
In-segment diameter stenosis(%).
时间窗: 9 months after the operation.
次要结局
- cardiac death.(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
- acute thrombosis(in month-1, 6, 9, 12 and year-2, 3, 4, 5)
- sub-acute thrombosis(in month-1, 6, 9, 12 and year-2, 3, 4, 5)
- end-stage thrombosis(in month-1, 6, 9, 12 and year-2, 3, 4, 5)
- myocardial infarction(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
- delayed thrombosis(in month-1, 6, 9, 12 and year-2, 3, 4, 5)
- myocardial infarction related to the target vessel.(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
- any target lesion revascularization(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
- The success rate of intervention treatment (%),including device success, lesion success and clinical success.(1-2 days.)
- In-device diameter stenosis (%) of the target lesion.(9 months after the operation.)
- target lesion revascularization driven by ischemia.(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
- all-cause death(in month-1, 6, 9, 12 and year-2, 3, 4, 5.)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent RestenosisCoronary RestenosisNCT02944890ZhuHai Cardionovum Medical Device Co., Ltd.242
已完成
不适用
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo LesionsCoronary Artery DiseaseNCT05096442Genoss Co., Ltd.204
Unknown
4 期
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary ArteriesCoronary Artery DiseaseNCT01903902Gachon University Gil Medical Center1,000
已完成
1 期
DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery DiseaseCoronary Artery DiseaseNCT00473772University Hospital, Saarland643
招募中
不适用
Durg Coated Balloon Angioplasty in Infrapopliteal LesionsPeripheral Artery DiseaseChronic Limb Threatening IschemiaArteriosclerosisNCT05620095Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology1,000