Clinical trial NCT02948257: VASCADE ANTEGRADE-PVD Post-Market Registry
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound
Keywords: Vessel closure
Antegrade access
Femoral arteriotomy
Peripheral endovascular interventions
Lead sponsor: Cardiva Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath

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).

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.

Primary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: Procedural, usually within 15 minutes of enrollment
measure: Major Access Site Closure-related Complications
timeFrame: Through 30 days +/- 7 days
Secondary outcomes:
measure: Time to Ambulation (TTA)
timeFrame: Prior to discharge, usually within 24 hours
measure: Time to Discharge (TTD)
timeFrame: Through hospital discharge, usually within 24 hours
measure: Device Success
timeFrame: Procedural, usually within 15 minutes of enrollment
measure: Procedure Success
timeFrame: Through 30 +/- 7 days
measure: Minor Access Site Closure-related Complications
timeFrame: Through 30 +/- 7 days
Other outcomes:
Locations:
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Tupelo
country: United States
facility: North MS Medical Center
state: Mississippi
city: Wilmington
country: United States
facility: Coastal Surgery Specialists
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: San Antonio
country: United States
facility: San Antonio Endovascular and Heart Institute
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: Mehdi Shishehbor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.