Evaluation of Diabetic Effects on Clinical Outcomes After Sirolimus-Eluting Stents in the AsIAN Population
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Cypher
- Registration Number
- NCT00997711
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
The purpose of this study is to evaluate the safety and performance of the CYPHER SELECT™+ Sirolimus-eluting Stent (SES) in Asian diabetic patients.
- Detailed Description
Study design This is a multi center, prospective, post market surveillance study of diabetic patients who underwent CYPHER SELECT™+ 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 SELECT™+ 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 SELECT™+ Sirolimus-eluting Coronary Stent is approved for commercial use. Data will be collected on approximately 3,600 subjects treated with the CYPHER SELECT™+ 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 SELECT™+ 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 953
- Patients receiving CYPHER SELECT™+ Sirolimus-eluting Coronary Stent
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, or sirolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
- Cardiogenic shock
- Terminal illness with life expectancy <1 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cypher Cypher Sirolimus-eluting stent
- Primary Outcome Measures
Name Time Method The composite of death, nonfatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) at 12 months post procedure. 12-month
- Secondary Outcome Measures
Name Time Method Composite of death or MI 12 months Stent thrombosis (ARC criteria) 12 months All Death 12-month Cardiac death 12 months MI (myocardial infarction) 12 months Composite of cardiac death or MI 12 months Target-lesion revascularization (TLR) 12 months Target- Vessel Revascularization (TVR) 12 months
Trial Locations
- Locations (14)
NHIC Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gyeongsang Uniservity Hospital
🇰🇷Jinju, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Busan Saint Mary's Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
St.Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Korea University Hospital
🇰🇷Seoul, Korea, Republic of