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Coronary Artery Stenting

Phase 1

Coronary Artery Disease | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 20, 2011

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 Enrollment139
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00248079The Medtronic RESOLUTE Clinical TrialPHASE1 COMPLETED 139Nov 1, 2005Oct 1, 2011Oct 20, 20111 Australia
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Study Endpoints
Primary Endpoints
Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
9 months
Secondary Endpoints
Major adverse cardiac event (MACE) rate
30 days, 4, 6, 9 & 12 months
Acute success (device, lesion, and procedure)
4 or 9 Months
Target vessel failure (TVF)
9 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Coronary Artery StentingDEVICEInitial implant of drug eluting stent (zotarolimus)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient is at least 18 years old 2. Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery 3. Patient has clinical evidence of ischemic heart disease or a positive functional study 4. Female patients of chil...

Countries:Australia
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