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

Percutaneous Coronary Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034084
• Other study ID #: COLAR
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: April 22, 2015
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: January 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Institutional Review Board of Beijing Tiantan Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: June 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Angiography,
• Percutaneous Coronary
• Transradial Approach,

Intervention

Procedure:
• left radial approach
Coronary diagnostic procedures performed through left radial approach
• Right radial approach
coronary diagnostic procedures performed through right radial approach

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular complications	Vascular complications include stroke, pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.	7 days	Yes
Primary	Total procedural duration		1 day	Yes
Secondary	Fluoroscopy time		7 days	Yes
Secondary	Dose of radiation	Dose of radiation include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)	7 days	Yes
Secondary	Contrast volume		7 days	Yes