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percutaneous coronary intervention

Phase 2

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

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,326
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00292474TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting StentPHASE2 COMPLETED 1,326 — — Mar 1, 2002Aug 1, 2007Oct 8, 20081 United States
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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 — 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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Competitive Landscape -Coronary Artery Disease 99 trials
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Ziltivekimab, Tocilizumab, Dobutamine, NaCl 0.9%
Boston Scientific CorporationBSX9PHASE3Undisclosed
Novartis AG Sponsored ADRNVS4PHASE3Inclisiran
Alnylam Pharmaceuticals, IncALNY1PHASE3Zilebesiran
Viatris, Inc.VTRS1PHASE3Selatogrel
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib + ezetimibe daily
GE Healthcare Technologies Inc.GEHC3PHASE1Regadenoson
Abbott LaboratoriesABT12 — Undisclosed
HeartFlow, Inc.HTFL5 — Rosuvastatin
Medtronic PlcMDT3NAUndisclosed
Teleflex IncorporatedTFX2NAUndisclosed
AstraZeneca PLCAZN1 — Tezepelumab
BioCardia, Inc.BCDA1NAUndisclosed
Sanofi SA Sponsored ADRSNY1 — alirocumab /2week, statin ± ezetimibe
Johnson & JohnsonJNJ1NAUndisclosed
Orchestra BioMed Holdings, Inc.OBIO1NAUndisclosed
Rhythm Pharmaceuticals, Inc.RYTM2NAUndisclosed
Azienda Ospedaliera Universitaria Integrata VeronaVRNA2 — Undisclosed
Healthcare Services Group, Inc.HCSG1 — Undisclosed
Collegium Pharmaceutical, Inc.COLL1 — Flozin
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