VASCADE ANTEGRADE-PVD Post-Market Registry

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: Cardiva Medical VASCADE VCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Minor Access Site Closure-related Complications | Patient incident rate of combined minor access site closure-related complications through 30 days | Through 30 +/- 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vessel closure, Antegrade access, Femoral arteriotomy, Peripheral endovascular interventions