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Completed

NCT Number: NCT01794325

Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.

The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.

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Key information

Conditions

Exposure to Ionizing Radiation Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Vascular Access Complication Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90520-000, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for a elective coronary angiography
  • Eligible for either transfemoral or transradial approach
  • Accept to sign the written consent form (WCF)

Exclusion criteria

  • Refusal to sign the WCF
  • End stage renal failure
  • Urgency/Emergency procedure
  • Contraindication to perform both coronary and left ventricle angiogram
  • Necessity of another vascular angiogram during coronary angiography

Treatment and study plan

Trans-radial

Other

Coronary angiography performed through trans-radial access

Trans-femoral

Other

Coronary angiography performed through trans-femoral access

Primary outcomes

  1. Patient radiation exposure (mGy)

    Time frame: during coronary angiography

    Patient radiation exposure (mGy)

Secondary outcomes

  1. Physician radiation exposure (in uSv)

    Time frame: during coronary angiography

    Physician radiation exposure (in uSv)

Other outcomes

  1. Major adverse cardiac events

    Time frame: 30 days

    Major adverse cardiac events (death, stroke and vascular complications)

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Collaborators

  • Hospital Ernesto Dornelles

Registry information

Official study title

Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial

Acronym: EXPERT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 18, 2013
Registry last updated
Sep 17, 2014

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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