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

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ClinicalTrials.gov Identifier: NCT02034084
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Buxing Chen, Capital Medical University

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.


Condition or disease Intervention/treatment Phase
Transradial Approach, Coronary Angiography, Percutaneous Coronary Procedure: left radial approach Procedure: Right radial approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Right radial approach
Coronary diagnostic procedures performed through right radial approach
Procedure: Right radial approach
coronary diagnostic procedures performed through right radial approach

Experimental: Left radial approach
Coronary diagnostic procedures performed through left radial approach
Procedure: left radial approach
Coronary diagnostic procedures performed through left radial approach




Primary Outcome Measures :
  1. Total procedural duration [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Fluoroscopy time [ Time Frame: 7 days ]
  2. Dose of radiation [ Time Frame: 7 days ]
    Dose of radiation include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)

  3. Contrast volume [ Time Frame: 7 days ]

Other Outcome Measures:
  1. Vascular complications [ Time Frame: 7 days ]
    Vascular complications include stroke, pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034084


Locations
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China
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Buxing Chen, Dr Beijing Tiantan Hospital
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Responsible Party: Buxing Chen, Director of department of cardiology, Capital Medical University
ClinicalTrials.gov Identifier: NCT02034084    
Other Study ID Numbers: COLAR
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: January 2014
Keywords provided by Buxing Chen, Capital Medical University:
Transradial approach,
Coronary angiography