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Manual Compression, Vascular Closure Device

Phase 3

Angioplasty, Transluminal, Percutaneous Coronary | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Jun 1, 2012

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment488
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00345631Safety and Effectiveness Study of the Ensure Medical Vascular Closure DevicePHASE3 COMPLETED 488Feb 1, 2007Sep 1, 2007Jun 1, 201217 United States
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Study Endpoints
Primary Endpoints
Time to Hemostasis (TTH)
From when the introducer sheath was removed to the time hemostasis was first observed

Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.

Time to Ambulation (TTA)
From when the introducer sheath was removed to 30 days post-procedure

Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.

Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure
From post-procedure to 30 days follow up

Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (\> 30 days) access site-related nerve injury.

Secondary Endpoints
Time to Eligibility for Hospital Discharge
From introducer sheath removal to hospital discharge, up to 284 hours
Time to Hospital Discharge
From introducer sheath removal to patient discharge
Time to Device Deployment, up to 5 Minutes
From device inserted to introducer sheath removal
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Manual CompressionACTIVE_COMPARATORManual compression (MC)
Vascular Closure DeviceEXPERIMENTALVascular Closure Device (VCD)
Interventions
NameTypeDescription
Manual CompressionOTHERManual compression
Vascular Closure DeviceDEVICEInvestigational vascular closure device
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Scheduled for a coronary or peripheral diagnostic or interventional procedure * Able to undergo emergent vascular surgery if a complication requires it * 6F arterial puncture located in the common femoral artery * Femoral artery has a lumen diameter of at least 5 mm Exclusion...

Countries:United States
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