Recent Updates
Recently added Catalysts

stent implantation

Phase 3

Arterial Occlusive Disease | Unknown | Other |Boston Scientific Corporation|Last Updated: Sep 29, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00352222Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac ArteriesPHASE3 COMPLETED 150 — — Jan 1, 2004Feb 1, 2007Sep 29, 200810 Belgium, Canada +3
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Angiographic mean percent loss of luminal diameter at 6 months post-procedure defined as ((post-procedure MLD - Follow-up MLD)/Post-procedure MLD) X 100
Secondary Endpoints
hemodynamic success at hospital discharge, 30 days and 6, 12 and 24 months post-procedure, angiographic binary restenosis at 6 mont
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
stent implantationDEVICE -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * chronic symptomatic atherosclerotic disease in the iliac arteries (Fontaine Class IIa, IIb, and III) * atherosclerotic de novo or restenotic lesions in the common and/or external iliac artery. * baseline diameter stenosis of \> or = 50% * reference vessel diameter \> or = 5mm ...

Countries:BelgiumCanadaCzechiaNetherlandsPoland
Unlock Eligibility Criteria