VASCADE ANTEGRADE-PVD Post-Market Registry

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-19

Study Completion Date

2017-09-18

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.

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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).

Conditions

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Surgical Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No