The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
UC Davis Medical Center
Sacramento, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Time to Hemostasis
Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis
Time frame: procedural, usually within 15 minutes of enrollment
Rate of Combined Major Access Site Closure-related Complications
Primary safety endpoint - rate of combined major access site closure-related complications
Time frame: Through 30 days +/- 7 days
Time to Ambulation
Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site
Time frame: prior to hospital discharge, usually within 24 hours
Time to Discharge Eligibility
Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)
Time frame: prior to hospital discharge, usually within 24 hours
Time to Hospital Discharge
Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward
Time frame: through hospital discharge, usually within 24 hours
Device Success
Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression
Time frame: procedural, usually within 15 minutes of enrollment
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Lafayette General Medical Center/Cardiovascular Institute of the South
Lafayette, Louisiana, United States
New York Presbyterian Hospital
New York, New York, United States
North Ohio Research
Elyria, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Geisinger Health Center
Danville, Pennsylvania, United States
Geisinger Health Center
Wilkes-Barre, Pennsylvania, United States
...and 2 more locations
Rate of Combined Minor Access Site Closure-related Complications
Secondary safety endpoint - rate of combined minor access site closure-related complications
Time frame: through 30 +/- 7 days
Procedure Success
Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days
Time frame: through 30 days +/- 7 days