CYPRESS - CYPHER for Evaluating Sustained Safety

Status Active, not recruiting

Clinical Trial Summary

CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)

Clinical Trial Description

During Phase I (non-randomized phase) of this study, the primary objective is to assess the rate of target lesion failure in subjects implanted with the CYPHER® stent and receiving dual antiplatelet therapy for 12 months.

During Phase II (randomized phase) of this study, the primary objective is to assess safety (major and minor bleeding), MACCE, and ST rates in subjects treated with dual antiplatelet therapy for 12 or 30 months following CYPHER® stent implantation.

*Subjects treated with the CYPHER® 2.25mm stent will be followed through 60 months.

**The last 500 patients enrolled will not be eligible for randomization. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00954707
Study type	Interventional
Source	Cordis Corporation
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	August 2009
Completion date	March 2016

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