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Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165035
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
Conor Medsystems
Information provided by:
Cordis Corporation

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date August 4, 2011
Study Start Date  ICMJE May 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
  • MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death [ Time Frame: 8 months ]
  • In-segment late lumen loss [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • MACE at 8 months defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
  • In-segment late lumen loss at 9 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
  • Device, lesion and procedure success [ Time Frame: At procedure or hospital discharge ]
  • Incidence of MACE [ Time Frame: 30 days, 9 months and 12 months ]
  • Coronary angiography in the angiographic cohort [ Time Frame: 9 months ]
  • Target lesion revascularization [ Time Frame: 8 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Device, lesion and procedure success
  • MACE at 30 days, 9 months and 12 months
  • Coronary angiography at 9 months in the angiographic cohort
  • Target lesion revascularization at 8 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
Official Title  ICMJE Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries
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.
Detailed Description Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Disease
Intervention  ICMJE
  • Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
    Drug eluting stent
  • Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
    Drug eluting stent
Study Arms  ICMJE
  • Experimental: 1
    CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
    Intervention: Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
  • Active Comparator: 2
    TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
    Intervention: Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
1701
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
1700
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General Inclusion Criteria:

  • 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)

Exclusion Criteria:

General Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165035
Other Study ID Numbers  ICMJE COSTAR II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitch W Krucoff, MD, Principal Investigator, Duke University Medical Center
Study Sponsor  ICMJE Cordis Corporation
Collaborators  ICMJE Conor Medsystems
Investigators  ICMJE
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, Ohio
Principal Investigator: Mitchell W Krucoff, MD Duke University Medical Center, Durham, NC
PRS Account Cordis Corporation
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP