Evaluation of Diabetic Effects on Clinical Outcomes After Sirolimus-Eluting Stents in the AsIAN Population

NCT ID: NCT00997711

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 953 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cypher

Sirolimus-eluting stent

Group Type: EXPERIMENTAL

Cypher

Intervention Type: DEVICE

Sirolimus-eluting stents

Interventions

Cypher

Sirolimus-eluting stents

Intervention Type: DEVICE

Other Intervention Names

Sirolimus-eluting stents

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Busan Saint Mary's Hospital

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

Countries

South Korea

Other Identifiers

2009-0119

Identifier Type: -

Identifier Source: org_study_id