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TAXUS Express2, Brachytherapy

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment488

FDA Designations

No designations recorded

Clinical trial landscape

TAXUS Express2, Brachytherapy · 1 trial · 1 indication

Phase 2 1
NCT00287573Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent RestenosisCoronary Restenosis
COMPLETED488 Analytics
PHASE2COMPLETED
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Coronary Restenosis
NCT00287573488
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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 to 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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Frequently asked questions about TAXUS Express2, Brachytherapy

What is TAXUS Express2 used for?

TAXUS Express2 is a paclitaxel-eluting coronary stent being studied for the treatment of coronary restenosis, specifically in-stent restenosis. It is designed to deliver the drug paclitaxel slowly to help prevent the recurrence of blockages in coronary arteries. The drug is currently in Phase 2 clinical development.

What does TAXUS Express2 target?

TAXUS Express2 targets the coronary artery tissue affected by restenosis. It is a drug-eluting stent that releases paclitaxel, an antiproliferative agent, to inhibit the growth of neointimal tissue that can cause re-narrowing of the artery after stent placement. The slow-release formulation is intended to provide sustained local drug delivery.

Who makes TAXUS Express2?

TAXUS Express2 is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the safety and efficacy of this paclitaxel-eluting coronary stent for treating coronary restenosis.

What phase is TAXUS Express2 in?

TAXUS Express2 is in Phase 2 clinical development. It is an investigational drug-eluting stent and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is no longer in active clinical trials according to the available data.

What clinical trials is TAXUS Express2 in?

TAXUS Express2 was evaluated in a completed Phase 2 clinical trial with the identifier NCT00287573. This randomized, active-controlled trial enrolled 488 participants with coronary restenosis across the United States and Canada. The study evaluated the slow-release formulation of the TAXUS paclitaxel-eluting coronary stent in treating in-stent restenosis.