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

NCT ID: NCT03716011

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2025-12-20

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAPT 3M or DAPT 12M

After stent implantation in DAPT 3M or DAPT 12M

Group Type: OTHER

EXCROSSAL

Intervention Type: DEVICE

a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent

Interventions

EXCROSSAL

a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Medical Systems Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao M Lu, Ph.D

Role: STUDY_DIRECTOR

Zhongshan hospital of ShangHai FuDan University

Locations

JW Medical System

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Lei M Ge, Ph.D

Role: CONTACT

ge.lei@zs-hospital.sh.cn

+86 10 50981788 ext. 2

Junbo M Ge, Ph.D

Role: CONTACT

ge.junbo@zs-hospital.sh.cn

+86 10 50981788 ext. 1

Facility Contacts

Wei M Fu, Bachelor

Role: primary

wei.fu@jwmsgrp.com

+86 10 50981788

Hao M Lu, Ph.D

Role: backup

haolu04@yahoo.com.cn

+86 10 50981788

Other Identifiers

DREAM-201810

Identifier Type: -

Identifier Source: org_study_id