Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
NCT ID: NCT00415961
Last Updated: 2009-01-09
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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TERMINATED
NA
120 participants
INTERVENTIONAL
2006-11-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
CoStar Paclitaxel drug eluting stent
CoStar Paclitaxel Drug-Eluting Coronary Stent System
CoStar Paclitaxel Drug-Eluting Coronary Stent System
Interventions
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CoStar Paclitaxel Drug-Eluting Coronary Stent System
CoStar Paclitaxel Drug-Eluting Coronary Stent System
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 ticlopidine
* Thrombocytopenia
* Active GI bleeding within past three months
* Known allergy to cobalt chromium
* Any prior true anaphylactic reaction to contrast agents
20 Years
95 Years
ALL
No
Sponsors
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Getz Pharma
INDUSTRY
Conor Medsystems
INDUSTRY
Responsible Party
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ShonanKamakura General Hospital
Principal Investigators
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Shigeru Saito, MD
Role: PRINCIPAL_INVESTIGATOR
ShonanKamakura General Hospital
Locations
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Shonan Kamakura General Hospital
Kamakura, , Japan
Countries
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Other Identifiers
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CI-CMS-005
Identifier Type: -
Identifier Source: org_study_id
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