The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADEâ„¢ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADEâ„¢ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADEâ„¢ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
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Time to Hemostasis (TTH)
Timeframe: Up to 1 hour
Rate of Combined Access Site-related Major Complications
Timeframe: 30 days +/- 7 days