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Lutonix Paclitaxel-Coated Balloon

Phase 1

In-Stent Restenosis | Unknown | Other |Becton, Dickinson and Company|Last Updated: Feb 27, 2017

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00916279PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent RestenosisPHASE1 COMPLETED 41 — — Jun 1, 2009Dec 1, 2011Feb 27, 20178 Belgium, Germany +1
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Study Endpoints
Primary Endpoints
Percent Diameter Stenosis (%DS) in the Analysis Segment
6 months
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
6 Months

Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.

Secondary Endpoints
Late Lumen Loss
6 months
MACE Rate
30 Days
Binary Restenosis
6 Months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lutonix CatheterEXPERIMENTAL -
Interventions
NameTypeDescription
Lutonix Paclitaxel-Coated BalloonDEVICEPTCA
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure; * Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina p...

Countries:BelgiumGermanyNetherlands
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