Prospective Registry on Vascular Access in Interventions in Lazio Region - Full Text View

Sponsored by:	San Filippo Neri General Hospital
Information provided by:	San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:	NCT00674778

Purpose

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
Postoperative Hemorrhages	Procedure: Any percutaneous cardiovascular procedure	Phase IV

U.S. FDA Resources

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

Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:

Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]

Enrollment:	1052
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2006

Arms	Assigned Interventions
1: Experimental Radial approach	Procedure: Any percutaneous cardiovascular procedure
2: Active Comparator Femoral approach	Procedure: Any percutaneous cardiovascular procedure

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria:

Patients already enrolled in other clinical trials

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674778

Sponsors and Collaborators

San Filippo Neri General Hospital

Investigators

Study Chair:

Giuseppe Richichi, MD

San Filippo Neri Hospital

More Information

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
Health Authority:	Italy: Ethics Committee

Keywords provided by San Filippo Neri General Hospital:

Radial
Femoral
artery
Invasive cardiology safety

Study placed in the following topic categories:

Postoperative Complications
Postoperative Hemorrhage
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009