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Sponsored by: |
San Filippo Neri General Hospital |
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Information provided by: | San Filippo Neri General Hospital |
ClinicalTrials.gov Identifier: | NCT00674778 |
Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.
We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.
Condition | Intervention | Phase |
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Postoperative Hemorrhages |
Procedure: Any percutaneous cardiovascular procedure |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Registry on Vascular Access in Interventions in Lazio Region |
Enrollment: | 1052 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
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1: Experimental
Radial approach
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Procedure: Any percutaneous cardiovascular procedure |
2: Active Comparator
Femoral approach
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Procedure: Any percutaneous cardiovascular procedure |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | San Filippo Neri Hospital ( Christian Pristipino, MD ) |
Study ID Numbers: | 1/6/2006 |
Study First Received: | May 5, 2008 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00674778 History of Changes |
Health Authority: | Italy: Ethics Committee |
Radial Femoral artery Invasive cardiology safety |
Postoperative Complications Postoperative Hemorrhage Hemorrhage |
Pathologic Processes Postoperative Complications Postoperative Hemorrhage Hemorrhage |