NCT04386213尚未招募不适用
A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Paclitaxel Drug-coated Coronary Artery Balloon Catheter in Patients With Coronary Artery In-stent Restenosis Compared to SeQuent® Please Paclitaxel Drug-coated Coronary Artery Balloon Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 216
- 主要终点
- In-segment Late Lumen Loss
研究概览
简要总结
This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.
详细描述
This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.
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 (Participant)
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
- •General Inclusion Criteria:
- •1.18-75 years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
- •Angiographic Inclusion Criteria:
- •One or two target lesions;
- •Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm;
- •The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia;
- •There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be >10mm.
排除标准
- •General Exclusion Criteria:
- •Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
- •Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <30% (ultrasound or left ventricular angiography);
- •The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
- •Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; which was judged to be clinically significant by the researchers;
- •Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
- •Subjects with bleeding tendency, antiplatelet preparation and anticoagulant treatment contraindications, subjects unable to receive antithrombotic treatment, or subjects unable to tolerate DAPT treatment for three months;
- •Previous history of peptic ulcer or gastrointestinal bleeding within 6 months;
- •Patients with cerebral vascular accident or transient ischemic attack (TIA) within the previous 6 months, or with permanent neurological defects that may lead to non-compliance with the protocol;
- •Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel;
- •The life expectancy of the subjects is less than 12 months;
- •The researcher judged that the subjects had poor compliance and could not complete the study as required;Or for other reasons that the researchers consider inappropriate;
- •Subjects who are participating in any other clinical trial, or who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the main study endpoint;
- •Pregnant or breast-feeding female subjects (women who may be pregnant must undergo a pregnancy test 7 days prior to baseline surgery).
- •Angiographic Exclusion Criteria:
- •In-stent restenosis without successful predilatation;
- •Stent restenosis of vein grafts;
- •Bridge stent restenosis;
- •All three vessels were diseased and needed revascularization;
- •Vessel diameter of branch opening in bifurcation lesions ≥2.5mm;
- •Complete occlusion of blood flow at TIMI level 0 (Mehran type IV stenosis);
- •The lesion was located in the left trunk and within 2mm from the opening.
结局指标
主要结局
In-segment Late Lumen Loss
时间窗: 9 months after coronary angiography
In-segment Late Lumen Loss
次要结局
- Clinical success(At time of procedure up to 7 days in hospital)
- Procedural success(Immediately after the index procedure)
- The number and rate of Thrombosis (per ARC definition)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- Device success(during the procedure)
- In-segment angiography binary restenosis (ABR, %)(9 months after index procedure)
- The number and rate of Target Lesion Revascularization (TLR)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- The number and rate of Target Vessel Revascularization (TVR)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- Device-oriented composite endpoints (Target Lesion Failure)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- Patient-oriented composite endpoint (PoCE)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- Death (Cardiac, Non-cardiac)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- The number and rate of Myocardial Infarction (MI)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
- The number and rate of Any Revascularization(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
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