Recent Updates
Recently added Catalysts

PRESILLION cobalt chromium stent

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Jun 14, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00722579A Study of the Presillion Stent in de Novo Coronary LesionsPHASE3 COMPLETED 101Jul 1, 2008Mar 1, 2010Jun 14, 20101 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR).
1-month and 6-months post-procedure
Secondary Endpoints
Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion.
1-month and 6-months post-procedure
Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel.
1-month and 6-months post-procedure
Target Vessel Failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
1-month and 6-months post-procedure
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALThe PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.
Interventions
NameTypeDescription
PRESILLION cobalt chromium stentDEVICEPTCA with bare-metal stent
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The patient must be \>= 18 years of age. * Patient is eligible for percutaneous coronary intervention (PCI). * Acceptable candidate for coronary artery bypass surgery (CABG). * Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to...

Countries:Belgium
Unlock Eligibility Criteria