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

Completed · Phase 3

Conditions studied: Coronary Disease

In brief

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.

Key facts

Study ID

NCT00165035

Run by

Cordis US Corp.

People needed

1701

Starts

2005-05-01

Expected to finish

2011-07-01

Last updated by the study team

2011-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Christ Linder — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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