The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).
Study Type
OBSERVATIONAL
Enrollment
52
At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.
Cardiovascular Institute of the South
Houma, Louisiana, United States
North MS Medical Center
Tupelo, Mississippi, United States
Coastal Surgery Specialists
Wilmington, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Time to Hemostasis (TTH)
Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
Time frame: Procedural, usually within 15 minutes of enrollment
Major Access Site Closure-related Complications
Patient incident rate of combined major access site closure-related complications through 30 days
Time frame: Through 30 days +/- 7 days
Time to Ambulation (TTA)
Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.
Time frame: Prior to discharge, usually within 24 hours
Time to Discharge (TTD)
Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
Time frame: Through hospital discharge, usually within 24 hours
Device Success
Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.
Time frame: Procedural, usually within 15 minutes of enrollment
Procedure Success
Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
Time frame: Through 30 +/- 7 days
Minor Access Site Closure-related Complications
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San Antonio Endovascular and Heart Institute
San Antonio, Texas, United States
Patient incident rate of combined minor access site closure-related complications through 30 days
Time frame: Through 30 +/- 7 days