NCT02688829已完成不适用
The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Count of Participants With MACE (Major Acute Cardiovascular Events)
研究概览
简要总结
This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18-75 years of age, males or non-pregnant females;
- •With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- •Total number of target lesion is 1;
- •Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
- •Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
- •Each target lesion may be covered by a single stent;
- •Patients with indications for coronary artery bypass graft surgery;
- •To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
排除标准
- •Within 1 month of any acute myocardial infarction;
- •Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge;
- •Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
- •In-stent Restenosis lesions;
- •Intracoronary implantation of any branding stents within 1 year;
- •Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
- •Preoperative renal function serum creatinine >2.0mg/DL;
- •Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
- •Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
- •The patient's life expectancy is less than 12 months;
- •Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
- •Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
- •Heart transplantation patients.
研究组 & 干预措施
treatment group
Experimental
Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
干预措施: Rapamycin target-eluting Coronary Stent System (Device)
结局指标
主要结局
Count of Participants With MACE (Major Acute Cardiovascular Events)
时间窗: 1 month after stent implantation
Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
次要结局
- Count of Participants With MACE (Major Acute Cardiovascular Events)(13 month after stent implantation)
- In-stent Late Lumen Loss(13 month after stent implantation)
- Percentage of In-stent Diameter Stenosis(13 month after stent implantation)
研究者
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
招募中
不适用
Pilot study to investigate the efficacy of rapamycin topical medicine against intractable hyperhidrosishyperhidrosisJPRN-UMIN000015874Department of Dermatology Graduate School of Medicine, Osaka University3
进行中（未招募）
1 期
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic MixCovid19NCT03305341Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair20
已完成
2 期
A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart AttacksAcute Myocardial InfarctionNCT00604695C. Michael Gibson, MS, MD40
招募中
Unknown
Clinical trial on the treatment of coronary microvascular disease with Shexiang Tongxin dropping pillcoronary microvascular diseaseITMCTR2024000027Guangdong provincial Hospital of Chinese Medicine