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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CoStar Paclitaxel Drug Eluting Coronary Stent System
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Percutaneous coronary intervention (PCI), Drug eluting stent (DES)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center
  • Christ Linder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Outcomes

Primary Outcome Measures

MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
In-segment late lumen loss

Secondary Outcome Measures

Device, lesion and procedure success
Incidence of MACE
Coronary angiography in the angiographic cohort
Target lesion revascularization

Full Information

First Posted
September 9, 2005
Last Updated
August 3, 2011
Sponsor
Cordis Corporation
Collaborators
Conor Medsystems
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1. Study Identification

Unique Protocol Identification Number
NCT00165035
Brief Title
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation
Collaborators
Conor Medsystems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Percutaneous coronary intervention (PCI), Drug eluting stent (DES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
Arm Title
2
Arm Type
Active Comparator
Arm Description
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
CoStar Paclitaxel Drug Eluting Coronary Stent System
Intervention Description
Drug eluting stent
Intervention Type
Device
Intervention Name(s)
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Intervention Description
Drug eluting stent
Primary Outcome Measure Information:
Title
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
Time Frame
8 months
Title
In-segment late lumen loss
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Device, lesion and procedure success
Time Frame
At procedure or hospital discharge
Title
Incidence of MACE
Time Frame
30 days, 9 months and 12 months
Title
Coronary angiography in the angiographic cohort
Time Frame
9 months
Title
Target lesion revascularization
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean J Kereiakes, MD
Organizational Affiliation
The Christ Hospital, Cincinnati, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitchell W Krucoff, MD
Organizational Affiliation
Duke University Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Christ Linder
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18599890
Citation
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.
Results Reference
result
PubMed Identifier
18420096
Citation
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.
Results Reference
result

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

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