Angio-Seal Interventional Radiology (IR) Registry

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

634 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.

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Detailed Description

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Conditions

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Diagnostic and/or Interventional Radiology Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Angio-Seal

Angio-Seal attempted and/or deployed

No interventions assigned to this group

Not deployed

Other method of closure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
2. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.