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TAXUS Express2, Brachytherapy

Phase 2

Coronary Restenosis | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Aug 6, 2010

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment488
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00287573Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent RestenosisPHASE2 COMPLETED 488 — — Jun 1, 2003Jan 1, 2010Aug 6, 201042 United States, Canada
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Study Endpoints
Primary Endpoints
Rate of Target Vessel Revascularization
9 Months
Secondary Endpoints
Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE
assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years
Stent thrombosis rate
5 Years
Target Vessel Failure (TVF, defined as any ischemia-driven revascularization of the target vessel, MI related to the target vessel, or death related to the target vessel).
5 Years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TAXUS Express2DEVICEPaclitaxel-Eluting Coronary Stent System
Brachytherapy (beta source)PROCEDUREBrachytherapy (beta source)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Cumulative target lesion length is \</= 46 mm (visual estimate). * Reference vessel diameter (RVD) is \>/= 2.5 and \</= 3.75 mm (visual estimate) * Left ventricular ejection fraction (LVEF) is \>/= 25% Exclusion Criteria: * Any previous or planned treatment with a non-study ...

Countries:United StatesCanada
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