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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
San Filippo Neri General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hemorrhages focused on measuring Radial, Femoral, artery, Invasive cardiology safety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 5, 2008
    Last Updated
    May 7, 2008
    Sponsor
    San Filippo Neri General Hospital
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    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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