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TAXUS Liberté-, TAXUS Express

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Feb 2, 2012

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
CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment1,529
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00371423Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery LesionsPHASE3 COMPLETED 247Mar 1, 2005Sep 1, 2010Feb 2, 201225 United States, New Zealand +2
NCT00371475A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery LesionsPHASE3 COMPLETED 150Mar 1, 2005May 1, 2011Feb 2, 201225 United States, New Zealand +1
NCT00371748A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small VesselsPHASE3 COMPLETED 261Feb 1, 2005Apr 1, 2011Feb 2, 201225 United States, New Zealand +1
NCT00371709TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery LesionsPHASE3 COMPLETED 871Aug 1, 2004Mar 1, 2010Feb 2, 201262 United States, Australia +5
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Study Endpoints
Primary Endpoints
Analysis segment percent diameter stenosis at 9-months
9 Months
Percent diameter stenosis of the analysis segment at 9-months
9 Months
Percent diameter stenosis - analysis segment at 9 months
9 Months
9-Month Target Vessel Revascularization (TVR)
9 Months
Secondary Endpoints
Secondary Endpoints: Clinical procedural and technical success
5 years
Utilization parameters (equipment utilization, procedure time, fluoroscopic time and amount of contrast used)
9 Months
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure
5 Years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2OTHERControl data derived from ATLAS Workhorse Trial
Arm 3OTHERHistorical Comparator: control data derived from a TAXUS V de novo lesion size-matched cohort randomized to receive a 2.25 mm or 2.5 mm BMS
Interventions
NameTypeDescription
TAXUS Liberté™-SRDEVICEPaclitaxel-Eluting Coronary Stent System
TAXUS Liberté-SRDEVICEPaclitaxel-Eluting Coronary 38 mm Stent
TAXUS™ ExpressDEVICEPaclitaxel-Eluting Coronary Stent System
TAXUS™ Express2DEVICEPaclitaxel-Eluting Coronary Stent System
Express2DEVICECoronary Stent System
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

General Inclusion Criteria: 1. Patient is ≥18 years old. 2. Eligible for percutaneous coronary intervention (PCI) 3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia 4. Left ventricular ejection fraction (LVEF) of ≥25% 5. Acceptab...

Countries:United StatesNew ZealandSingaporeTaiwanAustraliaCanadaChina
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