Back to resultsTo Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
Primary Purpose
Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CGBio stent
Biomatrix flex
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- At least one lesion with a diameter stenosis >50%
- suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
- Gr 1 ≤TIMI flow
Exclusion Criteria:
- ST-segment elevation MI
- Bifurcation lesion
- Chronic total occulusion
- Restenosis lesion
- Graft vessel lesion
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
- Cardiogenic shock or hemodynamic compromise
- Existing impairment in liver and kidney.
Sites / Locations
- Soeul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CGBIO stent (DES)
Biomatrix flex(DES)
Arm Description
The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)
The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG
Outcomes
Primary Outcome Measures
in-segment late loss
angiographic in-segment late loss measure by QCA program
Secondary Outcome Measures
in-stent late loss
angiographic in-stent late loss measure by QCA program
MACE
death, MI and TVF
Restenosis rate
angiographic restenosis rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03089450
Brief Title
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
Official Title
A Multicenter, Subject-blinded, Randomized Study to Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent in Patients Undergoing Drug-eluting Stent Procedure After Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CGBio Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
Detailed Description
A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CGBIO stent (DES)
Arm Type
Experimental
Arm Description
The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)
Arm Title
Biomatrix flex(DES)
Arm Type
Active Comparator
Arm Description
The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG
Intervention Type
Device
Intervention Name(s)
CGBio stent
Intervention Description
Percutaneous Coronary Intervention
Intervention Type
Device
Intervention Name(s)
Biomatrix flex
Intervention Description
Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
in-segment late loss
Description
angiographic in-segment late loss measure by QCA program
Time Frame
9 month
Secondary Outcome Measure Information:
Title
in-stent late loss
Description
angiographic in-stent late loss measure by QCA program
Time Frame
9 month
Title
MACE
Description
death, MI and TVF
Time Frame
9 month
Title
Restenosis rate
Description
angiographic restenosis rate
Time Frame
9month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one lesion with a diameter stenosis >50%
suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
Gr 1 ≤TIMI flow
Exclusion Criteria:
ST-segment elevation MI
Bifurcation lesion
Chronic total occulusion
Restenosis lesion
Graft vessel lesion
Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
Cardiogenic shock or hemodynamic compromise
Existing impairment in liver and kidney.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Soo KIim, MD/PhD
Phone
+82-2-2072-2226
Email
usahyosoo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo KIim, MD/PhD
Organizational Affiliation
Soeoul national university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Young-Hyo Lim, MD/PhD
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junghan Yoon, MD/PhD
Organizational Affiliation
Wonju Severance Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soeul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD/PhD
Phone
+82-2-2072-2226
Email
usahyosoo@gmail.com
First Name & Middle Initial & Last Name & Degree
Eunkyung Lee
Phone
+82 2-2072-4034
Email
yordim.lee@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
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