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

August 3, 2011 updated by: Cordis Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1701

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Cincinatti, Ohio, United States, 45219
        • Christ Linder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
Drug eluting stent
ACTIVE_COMPARATOR: 2
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Drug eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-segment late lumen loss
Time Frame: 9 months
9 months
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Target lesion revascularization
Time Frame: 8 months
8 months
Device, lesion and procedure success
Time Frame: At procedure or hospital discharge
At procedure or hospital discharge
Incidence of MACE
Time Frame: 30 days, 9 months and 12 months
30 days, 9 months and 12 months
Coronary angiography in the angiographic cohort
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Collaborators

Conor Medsystems

Investigators

  • Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, Ohio
  • Principal Investigator: Mitchell W Krucoff, MD, Duke University Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSTAR II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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