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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to evaluate the safety and performance of the CYPHER SELECTâ„¢+ Sirolimus-eluting Stent (SES) in Asian diabetic patients.
Study design This is a multi center, prospective, post market surveillance study of diabetic patients who underwent CYPHER SELECTâ„¢+ Sirolimus-eluting Coronary Stent implantation. For comparison, non-diabetic patients treated with SES in the concurrent period will be simultaneously enrolled.
Data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECTâ„¢+ Sirolimus-eluting Coronary Stent during the index procedure. All subjects should be treated according to the Instructions For Use (IFU) including conduct of the stenting procedure and administration of anti-platelet and diabetic medications; any other medical therapy should be provided according to local standard care. Brief study design is as depicted in the following figure.
STUDY POPULATION The registry will be conducted at approximately 15 centers in Korea where CYPHER SELECTâ„¢+ Sirolimus-eluting Coronary Stent is approved for commercial use. Data will be collected on approximately 3,600 subjects treated with the CYPHER SELECTâ„¢+ Sirolimus-eluting Coronary Stent only. Assuming the proportion of diabetic patients as 30%, approximately 1,100 diabetic patients will be enrolled. Enrolled diabetic patients are confirmed and diagnosed with Diabetes before or during the index procedure hospitalization, i.e., those receiving active treatment with an oral hypoglycemic agent or insulin, patients with diagnosis of diabetes who were on dietary therapy alone or patients with an abnormal blood glucose level after an overnight fast. Enrolled non-diabetic patients should be treated with CYPHER SELECTâ„¢+ Sirolimus-eluting Coronary Stent only.
STUDY PROCEDURE As regulated by data protection and privacy laws and in accordance with local Ethics Committee requirements, subjects will be informed and requested to grant their approval to review their medical records and collect and analyze personal medical information, while maintaining the confidentiality of the records at all times. They will be also asked to agree to be contacted during a 1-year follow-up period. Subjects will be followed at 1, 6 and 12 months, by phone call, office visit, or by contacts with primary physicians or referring cardiologists, according to each investigator's preference. Angiographic follow up will be performed at the physician's discretion. In diabetic patients, fasting glucose level and HbA1c level assessment will be performed at the index procedure and at the 12-month follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher | Experimental | Sirolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cypher | Device | Sirolimus-eluting stents |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The composite of death, nonfatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) at 12 months post procedure. | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| All Death | 12-month | |
| Cardiac death | 12 months | |
| MI (myocardial infarction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | South Korea | ||||
| Busan Saint Mary's Hospital |
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| 12 months |
| Composite of death or MI | 12 months |
| Composite of cardiac death or MI | 12 months |
| Target- Vessel Revascularization (TVR) | 12 months |
| Target-lesion revascularization (TLR) | 12 months |
| Stent thrombosis (ARC criteria) | 12 months |
| Busan |
| South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| NHIC Ilsan Hospital | Ilsan | South Korea |
| Gyeongsang Uniservity Hospital | Jinju | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Korea University Hospital | Seoul | South Korea |
| St.Mary's Catholic Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D003643 | Death |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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