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Angioguard distal protection device, PTCA

Phase 2

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Jan 7, 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
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264030Distal Protection Combined With PTCA in AMI PatientsPHASE2 COMPLETED 56Mar 1, 2002Aug 1, 2004Jan 7, 20081 France
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Study Endpoints
Primary Endpoints
Absolute ST segment resolution.
post-PTCA
Secondary Endpoints
ST segment resolution (> 50% decrease).
pre- and post-PTCA
TIMI Frame Count
post PTCA
Composite endpoint of slow flow, no reflow or distal embolization.
at anytime
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHERPTCA
2OTHERPTCA with angioguard
Interventions
NameTypeDescription
Angioguard distal protection deviceDEVICEPTCA with the Angioguard distal protection device.
PTCAOTHERPTCA
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads; * Clinical indication of primary PTCA; * De novo or restenotic lesions in native coronary vessel, single vessel treatment only; * Target lesion stenosis is \> 80% (by visu...

Countries:France
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