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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00842179
Other study ID # CL-003
Secondary ID
Status Completed
Phase N/A
First received February 6, 2009
Last updated February 11, 2009
Start date June 2008
Est. completion date October 2008

Study information

Verified date February 2009
Source Clinyx, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2517
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Baptist Hospital of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Clinyx, LLC Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary major vascular complications 0-30 days (during Index hospitalization) Yes
Secondary Minor vascular complications 0-30 days (during index hospitalization) Yes
See also
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Completed NCT00998023 - Patient Comfort With Vascular Closure N/A
Completed NCT01858636 - Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
Active, not recruiting NCT04203329 - AMBULATE Same Day Discharge Registry
Not yet recruiting NCT06358157 - The Ladera Large Bore Closure Feasibility Study N/A
Completed NCT05027698 - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
Completed NCT03756558 - Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System N/A
Not yet recruiting NCT05822804 - Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture N/A