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drug eluting-stent, drug-eluting stent

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Sep 16, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment1,508
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232830The Study to Assess AMI Treated With Balloon Angioplasty.PHASE3 COMPLETED 715Oct 1, 2003Apr 1, 2009Sep 16, 20092 France, Germany
NCT00235170The Arterial Revascularization Therapies Study Part II.PHASE3 COMPLETED 607Feb 1, 2003Apr 1, 2009May 5, 20091 Netherlands
NCT00381420The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.PHASE3 COMPLETED 100Mar 1, 2001Jun 1, 2008Oct 31, 2008 -
NCT00234455A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.PHASE2 COMPLETED 86Jun 1, 2001Apr 1, 2007Apr 30, 20081 Italy
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Study Endpoints
Primary Endpoints
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
abscence of major adverse cardiac and cerebral vascular events (MACCE)
1 year
in-stent minimum lumen diameter (MLD)
8 months
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
6-months post-procedure
Secondary Endpoints
cardiac death
1, 3, 4 and 5 years post-procedure
recurrence of myocardial infarction
1, 3, 4 and 5 years post-procedure
revascularization of the target vessel (TVR)
1, 3, 4 and 5 years post-procedure
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCypher Sirolimus-eluting Coronary Stent
2ACTIVE_COMPARATORBare-metal stent
Interventions
NameTypeDescription
drug-eluting stentDEVICECypher Sirolimus-eluting Coronary Stent
bare-metal stentDEVICEany bare-metal stent brand
drug eluting-stentDEVICEPCI
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following: 1. ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial lead...

Countries:FranceGermanyNetherlandsItaly
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