Prospective Registry on Vascular Access in Interventions in Lazio Region
PREVAIL
1 other identifier
interventional
1,052
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 5, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedMay 8, 2008
May 1, 2008
May 5, 2008
May 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
in-hospital
Secondary Outcomes (1)
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
in-hospital
Study Arms (2)
1
EXPERIMENTALRadial approach
2
ACTIVE COMPARATORFemoral approach
Interventions
Eligibility Criteria
You may qualify if:
- All patients undergoing any percutaneous cardiovascular procedure
You may not qualify if:
- Patients already enrolled in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giuseppe Richichi, MD
San Filippo Neri Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 5, 2008
First Posted
May 8, 2008
Study Start
June 1, 2006
Study Completion
June 1, 2006
Last Updated
May 8, 2008
Record last verified: 2008-05