NCT01515228

Brief Summary

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

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

Timeline
Completed

Started Jan 2012

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

9 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

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

January 18, 2012

Last Update Submit

January 8, 2015

Conditions

Coronary Artery Disease

Keywords

requiring drug eluting stents

Outcome Measures

Primary Outcomes (1)

  • In-segment late luminal loss

    at 9 month angiographic follow-up

Secondary Outcomes (27)

  • All Death

    12 months

  • Cardiac death

    12 months

  • Myocardial infarction

    12 months

  • Target vessel revascularization (ischemia-driven)

    12 months

  • Target lesion revascularization (ischemia-driven)

    12 months

  • +22 more secondary outcomes

Study Arms (2)

Xience Prime stent

ACTIVE COMPARATOR

everolimus eluting stent

Device: Cilotax stent

Cilotax stent

EXPERIMENTAL

paclitaxel with cilostazol dual drug eluting stent

Device: Xience Prime

Interventions

Xience PrimeDEVICE

everolimus-eluting stent implantation

Also known as: everolimus-eluting stent
Cilotax stent
Cilotax stentDEVICE

paclitaxel with cilostazol dual drug eluting stent implantation

Also known as: paclitaxel with cilostazol dual drug eluting stent
Xience Prime stent

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical:
  • Diabetic patients with active treatment (oral agent or insulin)
  • Patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age \> 20 years, \< 75 years
  • Angiographic:
  • 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)
  • ST-elevation acute myocardial infraction requiring primary stenting
  • 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 ≥ 3times normal
  • Renal dysfunction, creatinine ≥ 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol
  • Contraindication to Paclitaxel or everolimus
  • 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Soon Chun Hyang University Hospital Cheonan

Cheonan, 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

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Cheol-Whan Lee, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

KR(9)