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4.0 CYPHER Sirolimus-Eluting Coronary Stent

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Dec 2, 2009

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232752Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery LesionsPHASE3 COMPLETED 100Sep 1, 2003Nov 1, 2009Dec 2, 20091 United States
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Study Endpoints
Primary Endpoints
The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
6 months post-procedure
Secondary Endpoints
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced
30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure
Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
6 months post-procedure
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
6 months post-procedure
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
4.0 CYPHER Sirolimus-Eluting Coronary StentDEVICE4.0 CYPHER Sirolimus-Eluting Coronary Stent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or non-pregnant female patients minimum 18 years of age 2. 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) OR patients with documented silent ...

Countries:United States
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