NCT03373695已完成不适用
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
DK Medical Technology (Suzhou) Co., Ltd.15 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2018年2月22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
- 260
- 试验地点
- 15
- 主要终点
- In-segment Late Lumen Loss
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.
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 who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
- •Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
- •Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- •Related to lesion:
- •Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm
- •Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
- •The distance between other lesion requires interventional therapy and the target lesion must be > 10mm
- •One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation
- •Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B
排除标准
- •Related to patients
- •Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
- •Patients with cardiogenic shock
- •The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation
- •Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
- •Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
- •Patients with severe congestive heart failure or NYHA grade IV heart failure
- •Patients with moderate or severe valvular heart disease
- •Patients who had heart transplantation
- •Patients with renal insufficiency (eGFR < 30mL/min)
- •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 are participating in any other clinical trials before reaching the primary endpoints
- •Patients who are unsuitable for the study according to the investigator due to other reasons
- •Related to the Lesion:
- •Patients with total occlusion at the target lesion
- •Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
- •Reference vessel diameter < 2.0mm
- •Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
- •3-vessel disease that all need to be intervened
- •The diameter of the branch lesions in the target lesion ≥ 2.5mm
- •LM lesions and Ostial lesion within 5mm to the root aorta
- •Non-target lesion was not intervened successfully before target lesions being intervened
- •Related to concomitant therapy:
- •Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
- •Patients known allergic to paclitaxel
- •Patients known allergic to contrast materials
研究组 & 干预措施
Dissolve™
Experimental
干预措施: Dissolve™ (Device)
SeQuent®Please
Active Comparator
干预措施: SeQuent®Please (Device)
结局指标
主要结局
In-segment Late Lumen Loss
时间窗: From the end of procedure to 9 months after the procedure
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.
次要结局
- Device success rate of the interventional therapy(From the start of index procedure to end of index procedure)
- Lesion success rate of the interventional therapy(From the start of index procedure to end of index procedure)
- Rate of restenosis in the target lesions(9 months after the procedure)
- Target lesion failure (TLF) rate(9 months after the procedure)
- Rate of major adverse cardiovascular events(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
- TLR rate(9 months after the procedure)
- Rate of all adverse events and severe adverse events(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
- Clinical success rate of the interventional therapy(7 days after the procedure)
- Target vessel revascularization (TVR) rate(9 months after the procedure)
研究者
研究点 (15)
Loading locations...
相似试验
已完成
不适用
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel DiseaseCoronary Small Vessel DiseaseNCT03376646DK Medical Technology (Suzhou) Co., Ltd.277
已完成
3 期
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With AbciximabAngioplasty, Transluminal, Percutaneous CoronaryNCT00271401Centocor, Inc.2,399
招募中
不适用
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary LithotripsyCoronary Artery DiseaseNCT06369142Deutsches Herzzentrum Muenchen666
已完成
1 期
The TRIMAXX Coronary Stent TrialCoronary Artery DiseaseNCT00596661Abbott Medical Devices100
已完成
不适用
Treatment of Coronary In-Stent RestenosisRestenosisNCT01735825University Hospital Ostrava199