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

NCT03716011 | Unknown DMC

• 1 other identifier: DREAM-201810
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target lesion failure at 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.

  12-month

Secondary Outcomes (3)

• 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.

Study Arms (1)

DAPT 3M or DAPT 12M

OTHER

After stent implantation in DAPT 3M or DAPT 12M

Device: EXCROSSAL

Interventions

EXCROSSAL DEVICE

a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent

DAPT 3M or DAPT 12M

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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; 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;

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

JW Medical System

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hao M Lu, Ph.D

  Zhongshan hospital of ShangHai FuDan University

  STUDY DIRECTOR

Central Study Contacts

Lei M Ge, Ph.D

CONTACT

+86 10 50981788; ge.lei@zs-hospital.sh.cn

Junbo M Ge, Ph.D

CONTACT

+86 10 50981788; ge.junbo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 23, 2018
• Study Start: December 20, 2018
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2025
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CN (1)