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Keep this study
Lead
Cardiva Medical, Inc.
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).
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Acceptable candidate for post-procedural manual compression
Able to ambulate at least 20 feet, with or without assistance
You may not be if
Active systemic or cutaneous infection or inflammation
Ipsilateral femoral arteriotomy with any of the following conditions: a) access within \< or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within \< or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
Previous vascular grafts or surgery at the target vessel access site
Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
Femoral arterial diameter \< 6 mm at access site
Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
Length of tissue tract, the distance between the anterior arterial wall and skin, is \< 2.5 cm.
