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OpenTrials
Completed

NCT Number: NCT00842179

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

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Key information

Conditions

Vascular Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. major vascular complications

    Time frame: 0-30 days (during Index hospitalization)

Secondary outcomes

  1. Minor vascular complications

    Time frame: 0-30 days (during index hospitalization)

Sponsors and collaborators

Lead sponsor

Clinyx, LLC

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 12, 2009
Registry last updated
Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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