Left Versus Right Transradial Approach for Percutaneous Coronary Procedures (TALENT)
|ClinicalTrials.gov Identifier: NCT00821106|
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : March 19, 2010
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients [ Time Frame: 7 days ]
- Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications. [ Time Frame: 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821106
|Policlinico Casilino-ASL RMB|
|Università Cattolica del Sacro Cuore|
|Principal Investigator:||Alessandro Sciahbasi, MD||Policlinico Casilino ASL RMB|