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SPIRIT IV Clinical Study
Principal Investigator Name:
Jon R. Resar, M.D.
 
Study Coordinator Name:Kathleen M. Citro, R.N.

Contact Phone:410-955-7377

Contact E-mail:kcitro@jhmi.edu

Study Short Title:Spirit IV Clinical Trial

Study Long Title:A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions

IRB Number:WIRB 20060386

Funding Source:Advanced Cardiovascular Systems, Inc

Summary of Trial:To evaluate the safety and effectiveness of the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of up to three native coronary artery lesions, in patients who are referred for cardiac catherterization and possible coronary stenting. Patients will be randomized to receive either the investigational XIENCE V stent or the commercially available Taxus Express Paclitaxel-Eluting stent.

Inclusions:Blockage in a coronary artery which has not previously been treated with a stent.

Exclusions:The blockage has previously been treated with a stent, or is located in a coronary artery bypass graft. There are several exclusions which can only be evaluated at the time of the cardiac catheterization.

Clinical Trial Site:The Johns Hopkins Hospital 600 N. Wolfe Street Baltimore, MD 21287

Compensation for Participating?No

Start Date:2/2007

Anticipated End Date:12/2008

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