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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Closure

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 Type: Observational
• Enrollment (Actual): 2517

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who require vascular closure post percutaneous coronary intervention

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Manual Closure; Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI)
Perclose Device; Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
major vascular complications	0-30 days (during Index hospitalization)

Secondary Outcome Measures

Outcome Measure	Time Frame
Minor vascular complications	0-30 days (during index hospitalization)

Collaborators and Investigators

• Sponsor: Clinyx, LLC
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Jonathan Roberts, MD, Baptist Health South Florida

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (Estimate): February 12, 2009

Study Record Updates

• Last Update Posted (Estimate): February 12, 2009
• Last Update Submitted That Met QC Criteria: February 11, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Perclose
• Other Study ID Numbers: CL-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No