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

The purpose of this study is to evaluate the safety and performance of the CYPHER SELECT™+ Sirolimus-eluting Stent (SES) in Asian diabetic patients.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Cypher

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.

• Study Type: Interventional
• Enrollment (Actual): 953
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Busan Saint Mary's Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • NHIC Ilsan Hospital
  • Jinju, Korea, Republic of
    • Gyeongsang Uniservity Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Korea University Hospital
  • Seoul, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • St.Mary's Catholic Medical Center
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cypher; Sirolimus-eluting stent	Device: Cypher; Sirolimus-eluting stents; Other Names: Sirolimus-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite of death, nonfatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) at 12 months post procedure.	12-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac death	12 months
All Death	12-month
MI (myocardial infarction)	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Johnson & Johnson; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: October 18, 2009
• First Submitted That Met QC Criteria: October 18, 2009
• First Posted (ESTIMATE): October 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes; MI; death; TVR
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 2009-0119