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Completed

NCT Number: NCT02034084

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left radial approach

Procedure

Coronary diagnostic procedures performed through left radial approach

Right radial approach

Procedure

coronary diagnostic procedures performed through right radial approach

Primary outcomes

  1. Total procedural duration

    Time frame: 1 day

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 13, 2014
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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