VASCADE ANTEGRADE-PVD Post-Market Registry

Cardiva Medical

Status: Completed

Conditions: Surgical Wound

Treatments: Device: Cardiva Medical VASCADE VCS

Study type: Observational

Funder types: Industry

Identifiers

NCT02948257

PTL 0502-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design