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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EXCROSSAL
Sponsored by
JW Medical Systems Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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;

Sites / Locations

  • JW Medical System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DAPT 3M or DAPT 12M

Arm Description

After stent implantation in DAPT 3M or DAPT 12M

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MACE rate
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);
Device success rates , lesion success rates , clinical success rates
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.
Definite and probable stent thrombosis
According to ARC definition

Full Information

First Posted
October 17, 2018
Last Updated
October 22, 2018
Sponsor
JW Medical Systems Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03716011
Brief Title
A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2018 (Anticipated)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Medical Systems Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Subjects are eligible for coronary intervention The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
Masking
None (Open Label)
Allocation
N/A
Enrollment
2700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAPT 3M or DAPT 12M
Arm Type
Other
Arm Description
After stent implantation in DAPT 3M or DAPT 12M
Intervention Type
Device
Intervention Name(s)
EXCROSSAL
Intervention Description
a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent
Primary Outcome Measure Information:
Title
Target lesion failure at 12-Month
Description
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.
Time Frame
12-month
Secondary Outcome Measure Information:
Title
MACE rate
Description
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);
Time Frame
1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Title
Device success rates , lesion success rates , clinical success rates
Description
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.
Time Frame
1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Title
Definite and probable stent thrombosis
Description
According to ARC definition
Time Frame
1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei M Ge, Ph.D
Phone
+86 10 50981788
Ext
2
Email
ge.lei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Junbo M Ge, Ph.D
Phone
+86 10 50981788
Ext
1
Email
ge.junbo@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao M Lu, Ph.D
Organizational Affiliation
Zhongshan hospital of ShangHai FuDan University
Official's Role
Study Director
Facility Information:
Facility Name
JW Medical System
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei M Fu, Bachelor
Phone
+86 10 50981788
Email
wei.fu@jwmsgrp.com
First Name & Middle Initial & Last Name & Degree
Hao M Lu, Ph.D
Phone
+86 10 50981788
Email
haolu04@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Junbo M Ge, Ph.D
First Name & Middle Initial & Last Name & Degree
Lei M Ge, Ph.D
First Name & Middle Initial & Last Name & Degree
Yong M Huo, Ph.D
First Name & Middle Initial & Last Name & Degree
Jian an M Wang, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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