NCT01186107

Brief Summary

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2010

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

11 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

August 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

August 19, 2010

Last Update Submit

July 28, 2014

Conditions

Coronary Artery DiseaseDiabetes

Keywords

coronary diseasestent

Outcome Measures

Primary Outcomes (1)

  • Angiographic in-segment late loss

    9-month angiographic follow-up

Secondary Outcomes (5)

  • Death (all-cause and cardiac)

    at 12 months

  • myocardial infarction

    at 12 months

  • stent thrombosis

    at 12 months

  • target-lesion revascularization

    at 12 months

  • target-vessel revascularization

    at 12 months

Study Arms (2)

Endeavor Resolute stent

EXPERIMENTAL

zotarolimus-eluting stent

Device: Endeavor Resolute stent

Cypher stent

ACTIVE COMPARATOR

sirolimus-eluting stent

Device: Cypher stent

Interventions

Endeavor Resolute stentDEVICE

zotarolimus-eluting stent

Endeavor Resolute stent
Cypher stentDEVICE

sirolimus-eluting stent

Cypher stent

Eligibility Criteria

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

You may qualify if:

  • Diabetic patients with angina and documented ischemia
  • Patients who are eligible for intracoronary stenting
  • De novo lesion
  • Percent diameter stenosis ≥50%
  • Reference vessel size ≥ 2.5 mm by visual estimation

You may not qualify if:

  • History of bleeding diathesis or coagulopathy
  • Pregnant state
  • Known hypersensitivity or contra-indication to contrast agent and heparin
  • Limited life-expectancy (less than 1 year)
  • Acute ST elevation myocardial infarction on admission
  • Characteristics of lesion Left main disease In-stent restenosis Graft vessels
  • Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
  • Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
  • Renal dysfunction, creatinine ≥ 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol
  • Left ventricular ejection fraction \<30%
  • Patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period.
  • Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Location

Kangwon University Hospital

Chuncheon, South Korea

Location

Daejeon St Mary's Hospital Catholic University

Daejeon, South Korea

Location

GangNeung Asan Hospital

Gangneung, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul Veterans Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes MellitusCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Seung-Jung Park

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 23, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

KR(11)