Clinical trial NCT03716011: A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
Primary purpose: TREATMENT

Brief summary: 1. Prospective, randomized, multicenter clinical study
2. 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.
3. EDC system (eCRF electronic data collection system)
4. Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;

Detailed description: 1. Subjects are eligible for coronary intervention
2. The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
3. The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. De novo coronary artery primary lesions;
3. Stable angina pectoris;
4. Patients with coronary artery disease with similar symptoms of myocardial ischemia or angina;
5. Suitable for PCI indication and suitable for the implant of EXCROSSAL stents.
6. 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;

Exclusion Criteria:

1. Patients with acute myocardial infarction (AMI) within 7 days; Non-ST elevated ACS patients
2. those who implanted any stent before;
3. Left ventricular ejection score(LVEF) 30 %
4. Patients with bleeding tendency or anticoagulation treatment contraindications and/or PCI contraindications or coagulopathy;
5. 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;
6. It is estimated that elective surgery patients within 12 months;
7. Other coronary lesions requiring staged intervention;
8. If there are branches of blood vessels that need to be treated, the diameter of blood vessels ≥ 2.5 mm;
9. The subject's compliance or the researcher's judgment was not suitable for the participants in the study;
10. Pregnant or lactating persons; Imaging criteria

1. Left main disease, transplanted vessel lesions, stent restenosis; 2. The balloon cannot be predilated or/or the severe calcification lesion of rotatory failure; 3. The distortion of the stent is difficult to pass;

Primary outcomes:
measure: Target lesion failure at 12-Month
timeFrame: 12-month
Secondary outcomes:
measure: MACE rate
timeFrame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
measure: Device success rates , lesion success rates , clinical success rates
timeFrame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
measure: Definite and probable stent thrombosis
timeFrame: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Other outcomes:
Locations:
city: Beijing
country: China
facility: JW Medical System
state: Beijing
Study officials:
affiliation: Zhongshan hospital of ShangHai FuDan University
name: Hao M Lu, Ph.D
role: STUDY_DIRECTOR
References: