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to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGBIO stent (DES) | Experimental | The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C) |
|
| Biomatrix flex(DES) | Active Comparator | The abluminal biodegradable polymer DES BA9â„¢ (BIOLIMUS A9â„¢) DRUG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGBio stent | Device | Percutaneous Coronary Intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| in-segment late loss | angiographic in-segment late loss measure by QCA program | 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late loss | angiographic in-stent late loss measure by QCA program | 9 month |
| MACE | death, MI and TVF | 9 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Soo KIim, MD/PhD | Contact | +82-2-2072-2226 | usahyosoo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo KIim, MD/PhD | Soeoul national university hospital | Study Chair |
| Young-Hyo Lim, MD/PhD | Hanyang University | Principal Investigator |
| Junghan Yoon, MD/PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soeul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
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| Biomatrix flex |
| Device |
Percutaneous Coronary Intervention |
|
| Restenosis rate | angiographic restenosis rate | 9month |
| Wonju Severance Christian Hospital |
| Principal Investigator |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |