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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00842179

Enrollment

2517

Registered

2009-02-12

Start date

2008-06-30

Completion date

2008-10-31

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Closure

Keywords

Perclose

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results