NCT00997763

Brief Summary

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- 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
300

participants targeted

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

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

18 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

July 1, 2008

Completed
1.3 years 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
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

7.1 years

First QC Date

October 18, 2009

Last Update Submit

December 12, 2016

Conditions

Coronary Artery Disease

Keywords

stenting, XIENCE V, CYPHER

Outcome Measures

Primary Outcomes (1)

  • Angiographic in-segment late loss at angiography

    8-month

Secondary Outcomes (12)

  • All-cause Death

    12 month

  • All-cause Death

    5 year

  • Cardiac death

    12 months

  • Cardiac death

    5 year

  • Myocardial infarction

    12 months

  • +7 more secondary outcomes

Study Arms (2)

XIENCE V

ACTIVE COMPARATOR

everolimus-eluting stent

Device: XIENCE V

CYPHER

ACTIVE COMPARATOR

Using Cypher stent

Device: CYPHER

Interventions

XIENCE VDEVICE

everolimus-eluting stent

Also known as: Xience V stent
XIENCE V
CYPHERDEVICE

sirolimus-eluting stent

Also known as: Cypher elect stent
CYPHER

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 or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age \>18 years, \<75 ages
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Busan Saint Mary's Hospital

Busan, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Location

Cheongju Saint Mary's Hospital

Cheongju-si, South Korea

Location

Kangwon University Hospital

Chuncheon, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Daejeon St Mary's Hospital Catholic University

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Kyungsang University Hospital

Jinju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Pusan Natioanal University Hospital

Pusan, South Korea

Location

Hallym University Sacred Heart Hospital

Pyeongchon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Hallym University Sacred Heart Hospital

Seoul, South Korea

Location

Korea Veterans Hospital

Seoul, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCardiomyopathy, Dilated, 1C

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

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
MD, PhD

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

July 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations

KR(18)