VASCADE ANTEGRADE-PVD Post-Market Registry

Completed

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis (TTH)	Procedural, usually within 15 minutes of enrollment	Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
Major Access Site Closure-related Complications	Through 30 days +/- 7 days	Patient incident rate of combined major access site closure-related complications through 30 days

Secondary Outcome Measures

Name	Time	Method
Time to Ambulation (TTA)	Prior to discharge, usually within 24 hours	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 to Discharge (TTD)	Through hospital discharge, usually within 24 hours	Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
Device Success	Procedural, usually within 15 minutes of enrollment	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.
Procedure Success	Through 30 +/- 7 days	Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
Minor Access Site Closure-related Complications	Through 30 +/- 7 days	Patient incident rate of combined minor access site closure-related complications through 30 days

Locations (5): Cardiovascular Institute of the South
🇺🇸
Houma, Louisiana, United States
Coastal Surgery Specialists
🇺🇸
Wilmington, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
North MS Medical Center
🇺🇸
Tupelo, Mississippi, United States
San Antonio Endovascular and Heart Institute
🇺🇸
San Antonio, Texas, United States