Status:
COMPLETED
Angio-Seal Interventional Radiology (IR) Registry
Lead Sponsor:
Abbott Medical Devices
Conditions:
Diagnostic and/or Interventional Radiology Procedures
Eligibility:
All Genders
Brief Summary
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 interve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Patients who are unable to provide written informed consent.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
634 Patients enrolled
Trial Details
Trial ID
NCT01222104
Start Date
October 1 2010
End Date
May 1 2011
Last Update
February 5 2019
Active Locations (10)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
3
University of Florida
Gainesville, Florida, United States, 32610
4
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176