Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

Not Applicable

Completed

• Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Angiography
• Interventions: Procedure: Right radial; Procedure: left radial

• Registration Number: NCT00821106
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1540

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right transradial approach	Right radial	Coronary diagnostic or interventional procedures performed through right radial approach
Left transradial approach	left radial	Diagnostic or interventional procedures performed through left radial approach

Primary Outcome Measures

Name	Time	Method
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients	7 days

Secondary Outcome Measures

Name	Time	Method
Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.	7 days

Trial Locations

Locations (2)

Policlinico Casilino-ASL RMB; 🇮🇹 Rome, Italy

Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy