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EndoTex NexStent, Filter Wire EZ

Phase 3

Transient Ischemic Attack | Unknown | Neurology |Boston Scientific Corporation|Last Updated: Jan 24, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment488
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00600327Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™PHASE3 COMPLETED 488Dec 1, 2001Jun 1, 2007Jan 24, 200819 United States, Argentina +1
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Study Endpoints
Primary Endpoints
Major clinical events at one-year defined as any death, stroke or myocardial infarction
1 year
30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke.
1 year
Secondary Endpoints
NexStent™ technical success
post surgery
FilterWire EZ™ technical success
post surgery
Overall system technical success
post surgery
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
EndoTex™ NexStent™DEVICEEndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
Filter Wire EZ™DEVICEEPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * patient is greater than or equal to 18 years of age. * Anticipated patient life expectancy is of at least one year from the date of the index procedure. * Lesion is located in the common carotid artery (CCA) and/or the internal carotid artery (ICA) or the carotid bifurcation. ...

Countries:United StatesArgentinaGermany
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