To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
NCT ID: NCT03089450
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2017-03-22
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CGBIO stent (DES)
The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)
CGBio stent
Percutaneous Coronary Intervention
Biomatrix flex(DES)
The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG
Biomatrix flex
Percutaneous Coronary Intervention
Interventions
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CGBio stent
Percutaneous Coronary Intervention
Biomatrix flex
Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
80 Years
ALL
No
Sponsors
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CGBio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hyo-Soo KIim, MD/PhD
Role: STUDY_CHAIR
Soeoul national university hospital
Young-Hyo Lim, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Junghan Yoon, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Wonju Severance Christian Hospital
Locations
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Soeul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CG-DE-225-008
Identifier Type: -
Identifier Source: org_study_id
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