NCT03716011尚未招募不适用
A Large, Prospective, Randomized, Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System (Rapamycin) - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Target lesion failure at 12-Month
研究概览
简要总结
- Prospective, randomized, multicenter clinical study
- This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled.
- EDC system (eCRF electronic data collection system)
- Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;
详细描述
- Subjects are eligible for coronary intervention
- The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
- The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
- If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.
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
- •Age ≥18 years and ≤75 years;
- •De novo coronary artery primary lesions;
- •Stable angina pectoris;
- •Patients with coronary artery disease with similar symptoms of myocardial ischemia or angina;
- •Suitable for PCI indication and suitable for the implant of EXCROSSAL stents.
- •Able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and willing to accept the clinical follow-up; Imaging criteria The target lesion length≤ 60mm；Visual reference diameter of the vessel is 2.25-4.0mm;
排除标准
- •Patients with acute myocardial infarction (AMI) within 7 days; Non-ST elevated ACS patients
- •those who implanted any stent before;
- •Left ventricular ejection score(LVEF) 30 %
- •Patients with bleeding tendency or anticoagulation treatment contraindications and/or PCI contraindications or coagulopathy;
- •There are other diseases such as cancer, malignant tumor, congestive heart failure, organ transplant, or candidate) or has a history of abuse (alcohol, cocaine, heroin, etc.), plan adherence is poor, or the life expectancy of less than 1 year;
- •It is estimated that elective surgery patients within 12 months;
- •Other coronary lesions requiring staged intervention;
- •If there are branches of blood vessels that need to be treated, the diameter of blood vessels ≥ 2.5 mm;
- •The subject's compliance or the researcher's judgment was not suitable for the participants in the study;
- •Pregnant or lactating persons; Imaging criteria
- •Left main disease, transplanted vessel lesions, stent restenosis;
- •The balloon cannot be predilated or/or the severe calcification lesion of rotatory failure;
- •The distortion of the stent is difficult to pass;
研究组 & 干预措施
DAPT 3M or DAPT 12M
Other
After stent implantation in DAPT 3M or DAPT 12M
干预措施: EXCROSSAL (Device)
结局指标
主要结局
Target lesion failure at 12-Month
时间窗: 12-month
The target lesion failure (TLF) rate at 12 months after operation involves cardiac death, target-vessel myocardial infarction, and clinical-symptom driven target vessel revascularization.
次要结局
- MACE rate(1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.)
- Device success rates , lesion success rates , clinical success rates(1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.)
- Definite and probable stent thrombosis(1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOLLens OpacitiesCataractNCT06105190Cutting Edge SAS251
撤回
不适用
A Randomized Controlled Trial for Partial Knee ArthroplastyDegenerative Joint Disease of KneeTraumatic ArthritisVarus DeformityKnee Pain ChronicOsteoarthritisNCT05037734Zimmer Biomet
已完成
不适用
GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder SurgeryIntraoperative BleedingLiver DiseasesGallbladder DiseasesHemorrhage, SurgicalNCT05900037GATT Technologies BV53
已完成
不适用
GATT-Patch Versus TachoSil in Liver SurgeryIntraoperative BleedingHemorrhage, SurgicalLiver DiseasesNCT05385952GATT Technologies BV132
已完成
不适用
Minima Clinical StudyTotal Hip ArthroplastyNCT02414542Limacorporate S.p.a80