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

JW Medical Systems Ltd1 site in 1 country2,700 target enrollmentDecember 20, 2018

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: JW Medical Systems Ltd
Enrollment: 2700
Locations: 1
Primary Endpoint: Target lesion failure at 12-Month
Status: Not yet recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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;

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2018

End Date

December 20, 2025

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

JW Medical Systems Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Target lesion failure at 12-Month

Time Frame: 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.

Secondary Outcomes

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.)