Prospective Registry on Vascular Access in Interventions in Lazio Region (PREVAIL)

May 7, 2008 updated by: San Filippo Neri General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1052

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria:

  • Patients already enrolled in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Radial approach
Procedure: Any percutaneous cardiovascular procedure
Active Comparator: 2
Femoral approach
Procedure: Any percutaneous cardiovascular procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
Time Frame: in-hospital
in-hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
Time Frame: in-hospital
in-hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Filippo Neri General Hospital

Investigators

  • Study Chair: Giuseppe Richichi, MD, San Filippo Neri Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 7, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/6/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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