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

Completed

• Conditions: Vascular Closure

• Registration Number: NCT00842179
• Lead Sponsor: Clinyx, LLC

Brief 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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-11
• Last Update Submitted: 2009-02-11
• Study First Posted: 2009-02-12
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2517

Inclusion Criteria

• Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
• Patients who received vascular closure by manual compression at Tampa General Hospital

Exclusion Criteria

• Patients less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major vascular complications	0-30 days (during Index hospitalization)

Secondary Outcome Measures

Name	Time	Method
Minor vascular complications	0-30 days (during index hospitalization)

Trial Locations

Locations (1)

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States