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GAMMA-Iridium-192 catheter

Phase 1

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Apr 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 Enrollment579
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232778A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)PHASE1 COMPLETED 579May 1, 2000Jun 1, 2006Apr 24, 2008 -
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Study Endpoints
Primary Endpoints
The primary effectiveness parameters will be late thrombosis of the target lesion at
9 months for non-stented patients and late thrombosis of the target lesion at
15 months for stented patients.
The safety criteria will include post-procedure Q-wave myocardial infarction, non-Q-wave myocardial infarction, death, need for bypass surgery, need for emergency bypass surgery,or need for repeat coronary angioplasty.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GAMMA-Iridium-192 catheterDEVICE -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. The patient has a restenosis of \>60% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement. 2. The patient has a history, signs of, o...

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