A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Rate of Device procedural success (lesion level)
研究概览
简要总结
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
详细描述
The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA.
After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention.
Subjects will be followed through hospital discharge.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is at least 18 to 75 years of age, male or not pregnant female.
- •Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
- •De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
- •Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
- •Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
- •The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
- •Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
- •Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
排除标准
- •Evidence of ongoing acute myocardial infarction within a week.
- •Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
- •Severe calcification and Target lesion in a severe angulation (> 45 degrees).
- •Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%.
- •Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl.
- •Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
- •Patients with allergies to heparin and contrast media.
- •Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
- •Visible thrombus at the target lesion.
- •Patients received heart transplantation.
- •Participation in another clinical trial (12 months after index procedure).
- •Those who participated in another clinical trials, but did not reach the primary endpoint.
研究组 & 干预措施
SINOMED CBC
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
干预措施: SINOMED CBC (Device)
NSE Coronary Dilatation Catheter
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
干预措施: NSE Coronary Dilatation Catheter (Device)
结局指标
主要结局
Rate of Device procedural success (lesion level)
时间窗: immediate post-intervention(approximately 1.4 hour)
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis\<50%)
次要结局
- Incidence of any AE and SAE incidence(during the hospital stay, an average of 7 days post-procedure)
- Rate of Patient-oriented composite endpoint (POCE)(during the hospital stay, an average of 7 days post-procedure)
- Rate of Target lesion failure (TLF)(during the hospital stay, an average of 7 days post-procedure)
- Rate of Procedural success (patient level)(during the hospital stay, an average of 7 days post-procedure)
- Rate of device defect(during the hospital stay, an average of 7 days post-procedure)