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

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

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) ]

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

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)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who require vascular closure post percutaneous coronary intervention

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00842179

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

Responsible Party: Holly Taylor, Clinyx Identifier: NCT00842179     History of Changes
Other Study ID Numbers: CL-003
Study First Received: February 6, 2009
Last Updated: February 11, 2009

Keywords provided by Clinyx, LLC:
Perclose processed this record on July 24, 2017