Recent Updates
Recently added Catalysts

7F Ensure Medical Vascular Closure Device

Phase 1

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00574691ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EUPHASE1 COMPLETED 93 — — Jun 1, 2007Oct 1, 2007Feb 28, 20121 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time to hemostasis and time to ambulation.
at time introducer sheath is removed
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.
30 days
Secondary Endpoints
Device success.
initial hemostasis time ≤ 5 minutes and removal of the intact delivery system
Procedural success.
30 days
Time the patient is deemed eligible for hospital discharge.
time of the access site closure until patient is discharge
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHERVascular Closure Device
Interventions
NameTypeDescription
7F Ensure Medical Vascular Closure DeviceDEVICEVascular Closure Device
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient is between 18 and 85 years of age * Patient/legal representative provides written informed consent * Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure * Patient is able to undergo emergent vascular surgery if a complication relate...

Countries:Germany
Unlock Eligibility Criteria