Vascular Closure Clinical Trial
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
Verified date | February 2009 |
Source | Clinyx, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Baptist Hospital of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Clinyx, LLC | Abbott Vascular |
United States,
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 |
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