Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

Coronary Angiography Clinical Trial

— TALENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821106
• Other study ID #: TALENT
• Status: Completed
• Phase: N/A
• First received: January 9, 2009
• Last updated: March 18, 2010
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Policlinico Casilino ASL RMB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1540
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Coronary Angiography

Intervention

Procedure:
• Right radial
diagnostic or interventional procedures performed through right transradial approach
• left radial
diagnostic or interventional procedures performed through left transradial approach

Locations

Country	Name	City	State
Italy	Policlinico Casilino-ASL RMB	Rome
Italy	Università Cattolica del Sacro Cuore	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients		7 days	Yes
Secondary	Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.		7 days	Yes