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Cypher Select, Cypher

Phase 2

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Aug 6, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232791The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.PHASE2 COMPLETED 102Jan 1, 2004Mar 1, 2005Aug 6, 20081 United Kingdom
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Study Endpoints
Primary Endpoints
Angiographic in-stent late loss
6 months
Secondary Endpoints
In-stent mean percent diameter stenosis
anytime post-procedure
In-target vessel segment MLD
6 months
In-stent MLD
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCYPHER SELECT™ Sirolimus-eluting Coronary Stent
2ACTIVE_COMPARATORCYPHER™ Sirolimus-eluting Coronary Stent
Interventions
NameTypeDescription
Cypher SelectDEVICECYPHER SELECT™ Sirolimus-eluting Coronary Stent
CypherDEVICECYPHER™ Sirolimus-eluting Coronary Stent
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia; 2. Single treatment of de novo lesion in a coronar...

Countries:United Kingdom
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