At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
In Brief
A clinical study evaluating Manual compression and Cardiva VASCADE™ Vascular Closure System for Surgical Wound. Completed, enrolled 420 participants across 21 sites in 2 countries.
Detailed Summary
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ 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 VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
Study Details
Timeline
Interventions
Standard of Care
Investigational Hemostatic Vascular Closure System