Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

NCT ID: NCT00821106

Last Updated: 2010-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Coronary Angiography; Angioplasty, Transluminal, Percutaneous Coronary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Right transradial approach

Coronary diagnostic or interventional procedures performed through right radial approach

Group Type: EXPERIMENTAL

Right radial

Intervention Type: PROCEDURE

diagnostic or interventional procedures performed through right transradial approach

Left transradial approach

Diagnostic or interventional procedures performed through left radial approach

Group Type: EXPERIMENTAL

left radial

Intervention Type: PROCEDURE

diagnostic or interventional procedures performed through left transradial approach

Interventions

Right radial

diagnostic or interventional procedures performed through right transradial approach

Intervention Type: PROCEDURE

left radial

diagnostic or interventional procedures performed through left transradial approach

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Policlinico Casilino ASL RMB

OTHER

Sponsor Role: lead

Responsible Party

UOC Cardiologia-Policlinico Casilino-ASL RMB-Rome-Italy

Principal Investigators

Alessandro Sciahbasi, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Casilino ASL RMB

Locations

Policlinico Casilino-ASL RMB

Rome, , Italy

Università Cattolica del Sacro Cuore

Rome, , Italy

Countries

Italy

Other Identifiers

TALENT

Identifier Type: -

Identifier Source: org_study_id