Angio-Seal Interventional Radiology (IR) Registry

Abbott

Status: Completed

Conditions: Diagnostic and/or Interventional Radiology Procedures

Study type: Observational

Funder types: Industry

Identifiers

NCT01222104

0903

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. Patients who are unable to provide written informed consent.

Trial design

634 participants in 2 patient groups

Angio-Seal

Description:

Angio-Seal attempted and/or deployed

Not deployed

Description:

Other method of closure