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percutaneous coronary intervention

Phase 2

Coronary Artery Disease | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Oct 8, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,326

FDA Designations

No designations recorded

Clinical trial landscape

percutaneous coronary intervention · 1 trial · 1 indication

Phase 2 1
NCT00292474TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting StentCoronary Artery Disease
COMPLETED1,326 Analytics
PHASE2COMPLETED
TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of this study is to evaluate the safety and effectiveness of the TAXUS Stent System with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier syst

Secondary Endpoints

Secondary endpoints include the following:
• Rates of composite MACE and the individual components of MACE (MI, TVR, Cardiac Death), assessed at 1, 4 and 9 months after the index procedure and annually for 5 more years (i.e., 1, 2, 3, 4, and 5 years after the index procedure).
• Stent thrombosis rate
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAXUS ExpressEXPERIMENTAL -
Express BarePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
percutaneous coronary interventionDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient is \> or = 18 years old 2. Eligible for percutaneous coronary intervention (PCI) 3. Documented stable angina pectoris (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB...

Countries:United States
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Frequently asked questions about percutaneous coronary intervention

What is percutaneous coronary intervention used for?

Percutaneous coronary intervention is a procedure used to treat coronary artery disease. It involves opening narrowed or blocked coronary arteries to restore blood flow to the heart muscle. In the context of the TAXUS IV-SR trial, it was performed using a paclitaxel-eluting stent to treat de novo coronary lesions.

Who makes percutaneous coronary intervention?

Boston Scientific Corporation (ticker: BSX) is the developer of the percutaneous coronary intervention product evaluated in the TAXUS IV-SR trial. The company conducted a Phase 2 clinical study of this intervention in patients with coronary artery disease.

What phase is percutaneous coronary intervention in?

Percutaneous coronary intervention is in Phase 2 clinical development. The TAXUS IV-SR trial, which tested a single paclitaxel-eluting stent, was a Phase 2 study. The trial has been completed, and the intervention remains investigational for coronary artery disease.

What clinical trials is percutaneous coronary intervention in?

Percutaneous coronary intervention was studied in the TAXUS IV-SR trial (NCT00292474), a Phase 2, randomized, double-blind, placebo-controlled study. The trial enrolled 1,326 participants with coronary artery disease in the United States and has been completed.

Is percutaneous coronary intervention FDA approved?

The data provided does not indicate that percutaneous coronary intervention is FDA approved. It is an investigational intervention that was evaluated in a completed Phase 2 clinical trial. No approval status is stated, so it should be considered still in clinical development.

Is percutaneous coronary intervention the same as a paclitaxel-eluting stent?

Percutaneous coronary intervention is a procedure, and the TAXUS IV-SR trial used a paclitaxel-eluting stent as the intervention. The trial title specifies 'Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent,' indicating that the stent is the device used within the procedure.