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Cordimax China Post Market Surveillance

Primary Purpose

Coronary Artery Stenosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cordimax
XIENCE V
Sponsored by
Shandong Branden Med.Device Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Stents Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 18 years old or more
  2. patients with symptomatic coronary artery disease
  3. adapt to the DES treatment according to guide
  4. with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
  5. patients willing to participate and sign in research

Exclusion Criteria:

  1. Women in pregnancy or lactation
  2. Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
  3. Patients were banned to use the antiplatelet and/or anticoagulant therapy
  4. Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
  5. Patients who must stop clopidogrel to accept a elective surgery
  6. patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system

Sites / Locations

  • Zhongshan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cordimax

XIENCE V

Arm Description

Rapamycin Eluting Coronary Stent

Everolimus Eluting Coronary Stent

Outcomes

Primary Outcome Measures

Target Lesion Failure(TLF)
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization

Secondary Outcome Measures

Thrombotic events incidence
According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d
Major adverse cardiovascular events (MACE)
Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven
The Success Rate of Stent Placement
The stent can arrive and through the target lesion area, and can be expanded finally.
Operation Success Rate
After stent implantation, stent diameter stenosis < 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen.
Cost of the hospitalization
The total expenses in the process of operation
Length of stay
The total time consumption in the process of operation

Full Information

First Posted
May 16, 2017
Last Updated
June 12, 2017
Sponsor
Shandong Branden Med.Device Co.,Ltd
Collaborators
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03185221
Brief Title
Cordimax China Post Market Surveillance
Official Title
Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2013 (Actual)
Primary Completion Date
June 20, 2019 (Anticipated)
Study Completion Date
June 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Branden Med.Device Co.,Ltd
Collaborators
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world. Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
Detailed Description
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System. The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 4 mm. All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT. All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cordimax
Arm Type
Experimental
Arm Description
Rapamycin Eluting Coronary Stent
Arm Title
XIENCE V
Arm Type
Active Comparator
Arm Description
Everolimus Eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
Cordimax
Intervention Description
One rapamycin eluting stent for treating the adapted coronary patients
Intervention Type
Device
Intervention Name(s)
XIENCE V
Intervention Description
One everolimus eluting stent for treating the adapted coronary patients
Primary Outcome Measure Information:
Title
Target Lesion Failure(TLF)
Description
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization
Time Frame
at 1st year
Secondary Outcome Measure Information:
Title
Thrombotic events incidence
Description
According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d
Time Frame
at30 60 90 days and 1st 2st 3st 4st 5st year
Title
Major adverse cardiovascular events (MACE)
Description
Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven
Time Frame
at30 60 90 days and 1st 2st 3st 4st 5st year
Title
The Success Rate of Stent Placement
Description
The stent can arrive and through the target lesion area, and can be expanded finally.
Time Frame
in the operation
Title
Operation Success Rate
Description
After stent implantation, stent diameter stenosis < 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen.
Time Frame
0 to 24 hours after intervention
Title
Cost of the hospitalization
Description
The total expenses in the process of operation
Time Frame
0 to 24hours after discharge
Title
Length of stay
Description
The total time consumption in the process of operation
Time Frame
0 to 24 hours after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years old or more patients with symptomatic coronary artery disease adapt to the DES treatment according to guide with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5~4.0 mm) in diameter ;has the objective basis of myocardial ischemia patients willing to participate and sign in research Exclusion Criteria: Women in pregnancy or lactation Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation Patients were banned to use the antiplatelet and/or anticoagulant therapy Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project Patients who must stop clopidogrel to accept a elective surgery patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Cordimax China Post Market Surveillance

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