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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by CardioVascular Research Foundation, Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Johnson & Johnson
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00997711
First received: October 18, 2009
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: Cypher
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Diabetic Effects on Clinical Outcomes After Sirolimus-Eluting Stents in the AsIAN Population

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • The composite of death, nonfatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) at 12 months post procedure. [ Time Frame: 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Death [ Time Frame: 12-month ] [ Designated as safety issue: No ]
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • MI (myocardial infarction) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Composite of death or MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Composite of cardiac death or MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target- Vessel Revascularization (TVR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3600
Study Start Date: April 2009
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cypher
Sirolimus-eluting stent
Device: Cypher
Sirolimus-eluting stents
Other Name: Sirolimus-eluting stents

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997711

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Busan Saint Mary's Hospital
Busan, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
NHIC Ilsan Hospital
Ilsan, Korea, Republic of
Gyeongsang Uniservity Hospital
Jinju, 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
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
Johnson & Johnson
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00997711     History of Changes
Other Study ID Numbers: 2009-0119
Study First Received: October 18, 2009
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Diabetes
death
MI
TVR

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014