Prospective Registry on Vascular Access in Interventions in Lazio Region (PREVAIL)
Primary Purpose
Postoperative Hemorrhages
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Any percutaneous cardiovascular procedure
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Hemorrhages focused on measuring Radial, Femoral, artery, Invasive cardiology safety
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing any percutaneous cardiovascular procedure
Exclusion Criteria:
- Patients already enrolled in other clinical trials
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Radial approach
Femoral approach
Outcomes
Primary Outcome Measures
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
Secondary Outcome Measures
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
Full Information
NCT ID
NCT00674778
First Posted
May 5, 2008
Last Updated
May 7, 2008
Sponsor
San Filippo Neri General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00674778
Brief Title
Prospective Registry on Vascular Access in Interventions in Lazio Region
Acronym
PREVAIL
Official Title
Prospective Registry on Vascular Access in Interventions in Lazio Region
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
San Filippo Neri General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhages
Keywords
Radial, Femoral, artery, Invasive cardiology safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1052 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Radial approach
Arm Title
2
Arm Type
Active Comparator
Arm Description
Femoral approach
Intervention Type
Procedure
Intervention Name(s)
Any percutaneous cardiovascular procedure
Primary Outcome Measure Information:
Title
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
Time Frame
in-hospital
Secondary Outcome Measure Information:
Title
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
Time Frame
in-hospital
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing any percutaneous cardiovascular procedure
Exclusion Criteria:
Patients already enrolled in other clinical trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Richichi, MD
Organizational Affiliation
San Filippo Neri Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Prospective Registry on Vascular Access in Interventions in Lazio Region
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