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

This study has been completed.
Sponsor:
Collaborator:
Conor Medsystems
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00165035
First received: September 9, 2005
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • In-segment late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device, lesion and procedure success [ Time Frame: At procedure or hospital discharge ] [ Designated as safety issue: No ]
  • Incidence of MACE [ Time Frame: 30 days, 9 months and 12 months ] [ Designated as safety issue: Yes ]
  • Coronary angiography in the angiographic cohort [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 1701
Study Start Date: May 2005
Study Completion Date: July 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165035

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Christ Linder
Cincinatti, Ohio, United States, 45219
Sponsors and Collaborators
Cordis Corporation
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
  More Information

Publications:
Responsible Party: Mitch W Krucoff, MD, Principal Investigator, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00165035     History of Changes
Other Study ID Numbers: COSTAR II
Study First Received: September 9, 2005
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
Percutaneous coronary intervention (PCI)
Drug eluting stent (DES)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014