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

This study has been completed.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by:
Clinyx, LLC
ClinicalTrials.gov Identifier:
NCT00842179
First received: February 6, 2009
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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.


Condition
Vascular Closure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Further study details as provided by Clinyx, LLC:

Primary Outcome Measures:
  • major vascular complications [ Time Frame: 0-30 days (during Index hospitalization) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minor vascular complications [ Time Frame: 0-30 days (during index hospitalization) ] [ Designated as safety issue: Yes ]

Enrollment: 2517
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who require vascular closure post percutaneous coronary intervention

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00842179

Locations
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Sponsors and Collaborators
Clinyx, LLC
Abbott Vascular
Investigators
Principal Investigator: Jonathan Roberts, MD Baptist Health South Florida
  More Information

No publications provided

Responsible Party: Holly Taylor, Clinyx
ClinicalTrials.gov Identifier: NCT00842179     History of Changes
Other Study ID Numbers: CL-003
Study First Received: February 6, 2009
Last Updated: February 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Clinyx, LLC:
Perclose

ClinicalTrials.gov processed this record on August 26, 2014