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

Vascular Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842179
• Other study ID #: CL-003
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: February 11, 2009
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Clinyx, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2517
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Vascular Closure

Locations

Country	Name	City	State
United States	Baptist Hospital of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Clinyx, LLC	Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major vascular complications		0-30 days (during Index hospitalization)	Yes
Secondary	Minor vascular complications		0-30 days (during index hospitalization)	Yes