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Angioplasty of all peripheral AVF stenosis

Phase 3

Arteriovenous Fistula | Unknown | Nephrology |Boston Scientific Corporation|Last Updated: Aug 14, 2024

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06553443Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF StenosisPHASE3 RECRUITING 94Jan 4, 2024Dec 31, 2029Aug 14, 20241 Singapore
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Study Endpoints
Primary Endpoints
Access circuit primary patency
6 months

Time to next clinically-driven intervention

Secondary Endpoints
Access access circuit patency
12 months
Access circuit assisted primary patency
6 and 12 months
Access circuit secondary patency
6 and 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug-coated balloonEXPERIMENTALRanger drug-coated balloon will be used for all peripheral AVF stenosis.
Conventional balloonACTIVE_COMPARATORConventional balloon will be used for all peripheral AVF stenosis.
Interventions
NameTypeDescription
Angioplasty of all peripheral AVF stenosisDEVICEAll peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted. 2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed). 3. Less than 30% resi...

Countries:Singapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06553443primaryCompletionDate: changed
LOWMay 24, 2026NCT06553443studyFirstPostDate: changed