Left Versus Right Transradial Approach for Percutaneous Coronary Procedures (TALENT)

March 18, 2010 updated by: Policlinico Casilino ASL RMB

Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study

Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.

The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.

The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).

Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Universita Cattolica del Sacro Cuore
      • Rome, Italy
        • Policlinico Casilino-ASL RMB

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who undergo to diagnostic or interventional procedures

Exclusion Criteria:

  • Previous coronary artery by-pass
  • Acute myocardial infarction with ST segment elevation myocardial infarction
  • Cardiogenic shock
  • Ischemic Allen Test

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right transradial approach
Coronary diagnostic or interventional procedures performed through right radial approach
Procedure: Right radial
diagnostic or interventional procedures performed through right transradial approach
Experimental: Left transradial approach
Diagnostic or interventional procedures performed through left radial approach
Procedure: left radial
diagnostic or interventional procedures performed through left transradial approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Policlinico Casilino ASL RMB

Investigators

  • Principal Investigator: Alessandro Sciahbasi, MD, Policlinico Casilino ASL RMB

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

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TALENT

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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