Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgical Wound
- Sponsor
- Cardiva Medical, Inc.
- Enrollment
- 52
- Locations
- 5
- Primary Endpoint
- Time to Hemostasis (TTH)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acceptable candidate for post-procedural manual compression
- •Able to ambulate at least 20 feet, with or without assistance
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.
Outcomes
Primary Outcomes
Time to Hemostasis (TTH)
Time Frame: 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
Time Frame: Through 30 days +/- 7 days
Patient incident rate of combined major access site closure-related complications through 30 days
Secondary Outcomes
- Time to Ambulation (TTA)(Prior to discharge, usually within 24 hours)
- Time to Discharge (TTD)(Through hospital discharge, usually within 24 hours)
- Device Success(Procedural, usually within 15 minutes of enrollment)
- Procedure Success(Through 30 +/- 7 days)
- Minor Access Site Closure-related Complications(Through 30 +/- 7 days)