NCT00842179

Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device

Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,517 (actual)
• Sponsor: Clinyx, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

Detailed description

It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

Conditions

• Vascular Closure

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2009-02-12
• Last updated: 2009-02-12

Locations

1 site across 1 country: United States