NCT03376646已完成不适用
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease 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 277 人开始时间: 2018年6月20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
- 277
- 试验地点
- 15
- 主要终点
- In-segment percent diameter stenosis of the target lesion at 9 months after procedure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.
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:
- •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 (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
- •Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- •Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and
- •Patients who can receive balloon angioplasty
- •Related to lesion:
- •The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
- •Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
- •One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES)
- •Cohort B: All candidates for Cohort B of this study must meet number 6,7 of the above criteria and
- •The reference blood vessel diameter is 2.00mm-2.25mm
排除标准
- •Related to patients
- •Patients who had Myocardial Infarction within 1 week before being included
- •Patients with severe congestive heart failure or 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, or the patients have a bleeding tendency according to the investigator
- •Patients with leukopenia (white blood cell count < 3×10^9/L) for more than three days; Patients with low neutrophil counts (ANC < 1000/mm^3) for more than three days; Patients with thrombocytopenia (platelet count < 100,000/mm^3)
- •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 allergic to Paclitaxel or Zotarolimus
- •The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
- •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
- •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
- •Patients who have severe calcification of the target lesion, and balloon pre-dilatation 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) coronary requiring intervention treatment
- •More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion
研究组 & 干预措施
Cohort B: Dissolve™-2.00mm
Experimental
Cohort B is single arm.
干预措施: Cohort B: Dissolve™-2.00mm (Device)
Cohort A: Dissolve™
Experimental
干预措施: Cohort A: Dissolve™ (Device)
Cohort A: Resolute™ Integrity
Active Comparator
干预措施: Cohort A: Resolute™ Integrity (Device)
结局指标
主要结局
In-segment percent diameter stenosis of the target lesion at 9 months after procedure
时间窗: 9 months after the procedure
次要结局
- Binary restenosis rate in lesion section(9 months after the procedure)
- Target vessel revascularization (TVR) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
- Target lesion failure (TLF) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
- Lesion success rate of the interventional therapy(From the start of index procedure to the end of index procedure, Day 0)
- In-device late lumen loss (LLL)(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)
- 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)
- In-device percent diameter stenosis of the target lesion(9 months after the procedure)
- In-segment MLD(9 months after the procedure)
- Device success rate of the interventional therapy(From the start of index procedure to the end of index procedure, Day 0)
- Clinical success rate of the interventional therapy(7 days after the procedure)
- In-device minimal lumen diameter (MLD)(9 months after the procedure)
- In-segment LLL(9 months after the procedure)
- Target lesion revascularization (TLR) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
研究者
研究点 (15)
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