Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
NCT ID: NCT00165035
Last Updated: 2011-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1701 participants
INTERVENTIONAL
2005-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
CoStar Paclitaxel Drug Eluting Coronary Stent System
Drug eluting stent
2
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Drug eluting stent
Interventions
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CoStar Paclitaxel Drug Eluting Coronary Stent System
Drug eluting stent
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Drug eluting stent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Conor Medsystems
INDUSTRY
Cordis Corporation
INDUSTRY
Responsible Party
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Duke University Medical Center
Principal Investigators
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Dean J Kereiakes, MD
Role: PRINCIPAL_INVESTIGATOR
The Christ Hospital, Cincinnati, Ohio
Mitchell W Krucoff, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Center, Durham, NC
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Christ Linder
Cincinnati, Ohio, United States
Countries
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References
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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.
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.
Other Identifiers
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COSTAR II
Identifier Type: -
Identifier Source: org_study_id
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