Ischemic Heart Disease, NSTEMI - Non-ST Segment Elevation MI, Stable Angina, Stable Coronary Artery Disease, Unstable Angina
Conditions
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
Interventions
DEVICECGBio stent
Percutaneous Coronary Intervention
DEVICEBiomatrix flex
Percutaneous Coronary Intervention
Sponsors
CGBio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-segment late loss | 9 month | angiographic in-segment late loss measure by QCA program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| in-stent late loss | 9 month | angiographic in-stent late loss measure by QCA program |
| MACE | 9 month | death, MI and TVF |
| Restenosis rate | 9month | angiographic restenosis rate |
Countries
South Korea
Contacts
Primary ContactHyo-Soo KIim, MD/PhD
Outcome results
None listed