Recent Updates
Recently added Catalysts

Vascular access site closure

Phase 2

Angioplasty, Transluminal, Percutaneous Coronary | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Feb 28, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00533156Plug Arterial Closure System (PACS, 7F)PHASE2 COMPLETED 30 — — Jul 1, 2007Aug 1, 2007Feb 28, 20121 Mexico
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time to hemostasis following vessel access site closure
5 minutes post procedure
Time to ambulation following vessel access site closure
Post-procedure
Combined rate of closure related major adverse events at 30 days
Through 30 days
Secondary Endpoints
Device success (initial hemostasis within 5 minutes)
Within 5 minutes
Procedural success on day of catheterization and at 30 days (initial hemostasis by non-randomized treatment without closure related serious adverse events)
Through 30 days
Time patient is deemed eligible for hospital discharge relative to their access site closure
Up to hospital discharge
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Vascular access site closure (7F Ensure)DEVICE -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Scheduled for a coronary diagnostic or interventional procedure * Able to undergo emergent vascular surgery if a complication requires it * 7F arterial puncture located in the common femoral artery * Femoral artery has a lumen diameter of at least 5 mm Exclusion Criteria: * ...

Countries:Mexico
Unlock Eligibility Criteria