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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716011
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
JW Medical Systems Ltd

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;

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: EXCROSSAL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Intervention Model: Single Group Assignment
Intervention Model Description: the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2025

Arm Intervention/treatment
DAPT 3M or DAPT 12M
After stent implantation in DAPT 3M or DAPT 12M
Device: EXCROSSAL
a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. MACE rate [ Time Frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]

    Incidence of major adverse cardiac events (MACE) at different follow-up points of 1-month,3-month,6-month,12-month,24-month,36-month,48-month,60-montjh.

    2. Stent implantation success rate (covering the device success, the lesion success and the clinical success); 3. Target lesion failure (TLF) at 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation; 4. Subject-related cardio-clinical composite end points at the follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation, covering all-cause mortality, all myocardial infarctions and any revascularization; 5. The incidence of ARC-defined stent thrombosis events (defined, probable and non-excludable stent thrombosis in early, late, and delayed stages);


  2. Device success rates , lesion success rates , clinical success rates [ Time Frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]

    The success of the instrument refers to the degree of stenosis in the final bracket after the instrument was implanted. Lt; 30 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.

    The success of the lesion refers to the degree of ultimate diameter stenosis of the target lesion after the application of any interventional treatment. 50 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.

    The success of surgery refers to the absence of major cardiac adverse events caused by ischemia during the patient's hospitalization(up to 7 days after surgery) based on the success of the lesion.


  3. Definite and probable stent thrombosis [ Time Frame: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]
    According to ARC definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716011


Contacts
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Contact: Lei M Ge, Ph.D +86 10 50981788 ext 2 ge.lei@zs-hospital.sh.cn
Contact: Junbo M Ge, Ph.D +86 10 50981788 ext 1 ge.junbo@zs-hospital.sh.cn

Locations
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China, Beijing
JW Medical System
Beijing, Beijing, China, 100029
Contact: Wei M Fu, Bachelor    +86 10 50981788    wei.fu@jwmsgrp.com   
Contact: Hao M Lu, Ph.D    +86 10 50981788    haolu04@yahoo.com.cn   
Principal Investigator: Junbo M Ge, Ph.D         
Sub-Investigator: Lei M Ge, Ph.D         
Sub-Investigator: Yong M Huo, Ph.D         
Sub-Investigator: Jian an M Wang, Ph.D         
Sponsors and Collaborators
JW Medical Systems Ltd
Investigators
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Study Director: Hao M Lu, Ph.D Zhongshan hospital of ShangHai FuDan University

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Responsible Party: JW Medical Systems Ltd
ClinicalTrials.gov Identifier: NCT03716011    
Other Study ID Numbers: DREAM-201810
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases