Vascular Access Complication Clinical Trial
Official title:
Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
Clinical study in patients undergoing any intervention requiring vascular access to the
femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control
the vascular access.
It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.
Patients will have their puncture closure randomly performed by one of these approved
methods: Angio-Seal™ Closure device or Manual Compression.
Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks
(± 1 week).
The randomization will be stratified according to the type of procedure.
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