NCT00165035

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,701

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

1.7 years

First QC Date

September 9, 2005

Last Update Submit

August 3, 2011

Conditions

Coronary Disease

Keywords

Percutaneous coronary intervention (PCI)Drug eluting stent (DES)

Outcome Measures

Primary Outcomes (2)

  • MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death

    8 months

  • In-segment late lumen loss

    9 months

Secondary Outcomes (4)

  • Device, lesion and procedure success

    At procedure or hospital discharge

  • Incidence of MACE

    30 days, 9 months and 12 months

  • Coronary angiography in the angiographic cohort

    9 months

  • Target lesion revascularization

    8 months

Study Arms (2)

1

EXPERIMENTAL

CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES

Device: CoStar Paclitaxel Drug Eluting Coronary Stent System

2

ACTIVE COMPARATOR

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Interventions

CoStar Paclitaxel Drug Eluting Coronary Stent SystemDEVICE

Drug eluting stent

1
TAXUS™ Express2™ Paclitaxel-Eluting Coronary StentDEVICE

Drug eluting stent

2

Eligibility Criteria

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

You may qualify if:

  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
  • Documented LVEF ≥25% within the last 6 weeks.
  • Eligible for coronary artery bypass graft surgery (CABG)

You may not qualify if:

  • Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
  • Planned treatment with any other PCI device in the target vessel(s).
  • MI within 72 hours prior to the index procedure
  • Patient is in cardiogenic shock
  • Cerebrovascular Accident (CVA) within the past 6 months
  • Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
  • Contraindication to ASA or to clopidogrel
  • Thrombocytopenia
  • Active GI bleeding within past three months
  • Known allergy to stainless steel or cobalt chromium
  • Any prior true anaphylactic reaction to contrast agents
  • Patient is currently taking colchicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Christ Linder

Cincinnati, Ohio, 45219, United States

Location

Related Publications (2)

  • Kereiakes DJ, Petersen JL, Batchelor WB, Fitzgerald PJ, Mehran R, Lansky A, Tsujino I, Schofer J, Dubois C, Verheye S, Cristea E, Garg J, Wijns W, Krucoff MW. Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial. J Invasive Cardiol. 2008 Jul;20(7):335-41.

    PMID: 18599890RESULT

  • Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA 3rd, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB Jr, Schofer J, Buchbinder M, Wijns W; COSTAR II Investigators Group. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol. 2008 Apr 22;51(16):1543-52. doi: 10.1016/j.jacc.2008.01.020.

    PMID: 18420096RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Dean J Kereiakes, MD

    The Christ Hospital, Cincinnati, Ohio

    PRINCIPAL INVESTIGATOR

  • Mitchell W Krucoff, MD

    Duke University Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

May 1, 2005

Primary Completion

January 1, 2007

Study Completion

July 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(2)