A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT

JW Medical Systems

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: EXCROSSAL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03716011

DREAM-201810

Details and patient eligibility

About

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;

Full 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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

11. 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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,700 participants in 1 patient group

DAPT 3M or DAPT 12M

Other group

Description:

After stent implantation in DAPT 3M or DAPT 12M

Treatment:

Device: EXCROSSAL