VASCADE ANTEGRADE-PVD Post-Market Registry

Surgical Wound Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948257
• Other study ID #: PTL 0502-02
• Status: Completed
• Start date: January 19, 2017
• Est. completion date: September 18, 2017

Study information

• Verified date: January 2020
• Source: Cardiva Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• Cardiva Medical VASCADE VCS
At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	San Antonio Endovascular and Heart Institute	San Antonio	Texas
United States	North MS Medical Center	Tupelo	Mississippi
United States	Coastal Surgery Specialists	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cardiva Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis (TTH)	Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.	Procedural, usually within 15 minutes of enrollment
Primary	Major Access Site Closure-related Complications	Patient incident rate of combined major access site closure-related complications through 30 days	Through 30 days +/- 7 days
Secondary	Time to Ambulation (TTA)	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.	Prior to discharge, usually within 24 hours
Secondary	Time to Discharge (TTD)	Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.	Through hospital discharge, usually within 24 hours
Secondary	Device Success	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.	Procedural, usually within 15 minutes of enrollment
Secondary	Procedure Success	Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.	Through 30 +/- 7 days
Secondary	Minor Access Site Closure-related Complications	Patient incident rate of combined minor access site closure-related complications through 30 days	Through 30 +/- 7 days