Angio-Seal Interventional Radiology (IR) Registry

Completed

Conditions studied: Diagnostic and/or Interventional Radiology Procedures

In brief

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.

Key facts

Study ID

NCT01222104

Run by

Abbott Medical Devices

People needed

634

Starts

2010-10-01

Expected to finish

2011-05-01

Last updated by the study team

2019-02-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.

You may not qualify if…

• Patients who are unable to provide written informed consent.

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kaleida Health — Buffalo, New York, United States
• Mayfield Clinic, Inc.; The University Hospital — Cincinnati, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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