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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

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials4
Total Enrollment1,529

FDA Designations

No designations recorded

Clinical trial landscape

TAXUS Liberté- TAXUS Express · 4 trials · 1 indication

Phase 3 4
NCT00371423Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery LesionsCoronary Artery Disease
COMPLETED247 Analytics
NCT00371475A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery LesionsCoronary Artery Disease
COMPLETED150 Analytics
NCT00371748A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small VesselsCoronary Artery Disease
COMPLETED261 Analytics
NCT00371709TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery LesionsCoronary Artery Disease
COMPLETED871 Analytics
PHASE3COMPLETED
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
Coronary Artery DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about TAXUS Liberté- TAXUS Express

What is TAXUS Liberté used for?

TAXUS Liberté is a drug-eluting stent used for the treatment of coronary artery disease. It is designed to open narrowed or blocked coronary arteries and deliver a drug to help prevent restenosis. The stent is currently in Phase 3 clinical development and is not yet approved by the FDA.

Who makes TAXUS Liberté?

TAXUS Liberté is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting Phase 3 clinical trials to evaluate the safety and effectiveness of the stent in patients with coronary artery disease.

What phase is TAXUS Liberté in?

TAXUS Liberté is in Phase 3 clinical development. It is an investigational drug-eluting stent being studied for the treatment of coronary artery disease. The Phase 3 trials have been completed, but the product has not yet received FDA approval and remains under clinical investigation.

What clinical trials is TAXUS Liberté in?

TAXUS Liberté has been studied in four completed Phase 3 clinical trials: NCT00371423, NCT00371475, NCT00371709, and NCT00371748. These trials evaluated the stent in patients with de novo coronary artery lesions, including long lesions and small vessels, across multiple countries including the United States, New Zealand, Singapore, and Taiwan.

Is TAXUS Liberté the same as TAXUS Express?

TAXUS Liberté is a distinct stent system from TAXUS Express, though both are drug-eluting stents developed by Boston Scientific for coronary artery disease. The Liberté platform features a different stent design compared to the Express platform, and they have been studied in separate clinical trials.