NCT02944890已完成不适用
A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)
ZhuHai Cardionovum Medical Device Co., Ltd.14 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 14
- 主要终点
- In-segment late lumen loss of the target lesion
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
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
- Single (Outcomes Assessor)
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 agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-
- •Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
- •Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
- •Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- •Related to the diseases:
- •Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time
- •Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be ≥70%, or ≥50% with the evidence of ischemia.
- •One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.
- •The distance between lesions which require intervention and the target lesions must be >10mm.
排除标准
- •Related to the patients:
- •Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
- •The patients are participating in any other clinical trials before reaching the primary endpoints.
- •The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
- •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 who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
- •Patients with renal insufficiency (eGFR<30mL/min)
- •Patients who are known to be allergic to Paclitaxel
- •Patients who had myocardial infarction within 1 week before being included
- •Patients who had heart transplantation
- •Patients with severe congestive heart failure or NYHA grade IV heart failure
- •Patients with severe valvular heart disease
- •Patients who are unsuitable for the study according to the investigator due to other reasons
- •Related to the diseases:
- •Patients with evidence of extensive thrombosis in the target vessel before intervention
- •Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
- •Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery
- •Patients with lesions requiring intervention treatment in 3 vessels
- •The diameter of the branch lesions in the target lesion ≥2.5mm
- •Patients already treated with CABG after in-stent restenosis
- •LM lesions and Ostial lesion within 5mm to the root aorta
结局指标
主要结局
In-segment late lumen loss of the target lesion
时间窗: 9 months
次要结局
- Occurrence rate of major adverse cardiovascular events(1, 6, 9, and 12 months after the operation)
- Target lesion failure (TLF) rate(1, 6, 9, and 12 months after the operation)
- Occurrence rate of restenosis in the target lesions(9 months after the operation)
- Target lesion revascularization (TLR) rate(1, 6, 9, and 12 months after the operation)
- Target vessel revascularization (TVR) rate(1, 6, 9, and 12 months after the operation)
- The success rate of intervention treatment: including device success, lesion success and clinical success(1-2 days)
- All adverse events and severe adverse events(1, 6, 9, and 12 months after the operation)
研究者
研究点 (14)
Loading locations...
相似试验
Unknown
不适用
The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) PatientSmall Vessel DiseaseNCT03625830B. Braun Medical International Trading Company Ltd.270
已完成
4 期
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral ArteryArterial Occlusive DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesPaclitaxelPlaque, AtheroscleroticAtherosclerosisCritical Limb IschemiaPeripheral Arterial DiseaseArteriosclerosisNCT02212470Instituto Dante Pazzanese de Cardiologia85
已完成
不适用
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent RestenosisCoronary Artery DiseaseNCT04405063Genoss Co., Ltd.82
已完成
不适用
Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel DiseaseCoronary StenosisNCT02946307ZhuHai Cardionovum Medical Device Co., Ltd.240
已完成
不适用
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)Coronary RestenosisCoronary AtherosclerosisCoronary ArteriosclerosisCoronary Artery DiseaseNCT02151812Hemoteq AG123