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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821106
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : March 19, 2010
Sponsor:
Information provided by:
Policlinico Casilino ASL RMB

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Angiography Angioplasty, Transluminal, Percutaneous Coronary Procedure: Right radial Procedure: left radial Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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




Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821106


Locations
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Italy
Policlinico Casilino-ASL RMB
Rome, Italy
Università Cattolica del Sacro Cuore
Rome, Italy
Sponsors and Collaborators
Policlinico Casilino ASL RMB
Investigators
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Principal Investigator: Alessandro Sciahbasi, MD Policlinico Casilino ASL RMB
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Responsible Party: Alessandro Sciahbasi MD, UOC Cardiologia-Policlinico Casilino-ASL RMB-Rome-Italy
ClinicalTrials.gov Identifier: NCT00821106    
Other Study ID Numbers: TALENT
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: January 2010
Keywords provided by Policlinico Casilino ASL RMB:
Coronary angiography
percutaneous coronary intervention
Transradial approach