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

Last updated: August 3, 2011
Sponsor: Cordis Corporation
Overall Status: Completed

Phase

3

Condition

Atherosclerosis

Heart Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00165035
COSTAR II
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: General Inclusion Criteria:

  • Eligible for percutaneous coronary intervention (PCI)

  • Documented stable or unstable angina pectoris (Class I, II, III or IV), documentedischemia, or documented silent ischemia

  • Documented LVEF ≥25% within the last 6 weeks.

  • Eligible for coronary artery bypass graft surgery (CABG)

Exclusion

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

Study Design

Total Participants: 1701
Study Start date:
May 01, 2005
Estimated Completion Date:
July 31, 2011

Study 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.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Christ Linder

    Cincinatti, Ohio 45219
    United States

    Site Not Available

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