VASCADE ANTEGRADE-PVD Post-Market Registry

Completed

Conditions studied: Surgical Wound

In brief

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.

Key facts

Study ID

NCT02948257

Run by

Cardiva Medical, Inc.

People needed

52

Starts

2017-01-19

Expected to finish

2017-09-18

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acceptable candidate for post-procedural manual compression
• Able to ambulate at least 20 feet, with or without assistance

You may not qualify 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.

Where it is running

• 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
• San Antonio Endovascular and Heart Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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