NCT00997711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
953

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2009

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

October 18, 2009

Last Update Submit

November 16, 2015

Conditions

Coronary Artery Disease

Keywords

DiabetesdeathMITVR

Outcome Measures

Primary Outcomes (1)

  • The composite of death, nonfatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) at 12 months post procedure.

    12-month

Secondary Outcomes (8)

  • All Death

    12-month

  • Cardiac death

    12 months

  • MI (myocardial infarction)

    12 months

  • Composite of death or MI

    12 months

  • Composite of cardiac death or MI

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Cypher

EXPERIMENTAL

Sirolimus-eluting stent

Device: Cypher

Interventions

CypherDEVICE

Sirolimus-eluting stents

Also known as: Sirolimus-eluting stents
Cypher

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Busan Saint Mary's Hospital

Busan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

NHIC Ilsan Hospital

Ilsan, South Korea

Location

Gyeongsang Uniservity Hospital

Jinju, South Korea

Location

Hallym University Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

St.Mary's Catholic Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes MellitusDeath

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Seung-Jung Park, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

KR(14)