A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures

NCT ID: NCT02034084

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-06-30

Brief Summary

Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.

The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.

The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.

The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of vascular complications.

Conditions

Transradial Approach,; Coronary Angiography,; Percutaneous Coronary

Study Design

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

Study Groups

Right radial approach

Coronary diagnostic procedures performed through right radial approach

Group Type: EXPERIMENTAL

Right radial approach

Intervention Type: PROCEDURE

coronary diagnostic procedures performed through right radial approach

Left radial approach

Coronary diagnostic procedures performed through left radial approach

Group Type: EXPERIMENTAL

left radial approach

Intervention Type: PROCEDURE

Coronary diagnostic procedures performed through left radial approach

Interventions

left radial approach

Coronary diagnostic procedures performed through left radial approach

Intervention Type: PROCEDURE

Right radial approach

coronary diagnostic procedures performed through right radial approach

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All consecutive patients who undergo to diagnostic coronary procedures

Exclusion Criteria

• Acute ST-elevation myocardial infarction
• Previous coronary artery bypass graft surgery
• Hemodynamic instability

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Buxing Chen

Director of department of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buxing Chen, Dr

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

COLAR

Identifier Type: -

Identifier Source: org_study_id