The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths. Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
204
The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.
Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Alaska Heart & Vascular
Anchorage, Alaska, United States
Mercy General Hospital
Sacramento, California, United States
Stanford University Hospital
Stanford, California, United States
Time to Ambulation (TTA)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Time frame: Post-procedure, usually within 6 hours
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 +/- 7 days post-procedure
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered "minor" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 +/- 7 days post-procedure
Time to Discharge Eligibility (TTDE)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Hemostasis (TTH)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Centennial Medical Center
Nashville, Tennessee, United States
...and 3 more locations
Time frame: Post-procedure, usually within 3 hours
Time to Discharge (TTD)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Closure Eligibility (TTCE)
Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)
Time frame: Post-procedure, usually within 6 hours
Total Post-Procedure Time (TPPT)
Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time frame: Post-procedure, usually within 6 hours
Number of Participants With Procedure Success
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time frame: 30 +/- 7 days post-procedure
Number of Access Sites With Device Success
Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
Time frame: Procedural, usually within 15 minutes of enrollment