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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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

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Vascular Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Manual Closure

Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI)

No interventions assigned to this group

Perclose Device

Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI)

No interventions assigned to this group

Eligibility Criteria

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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