Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Patient radiation exposure (mGy)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient radiation exposure (mGy)
Time Frame: during coronary angiography
Patient radiation exposure (mGy)
Secondary Outcomes
- Physician radiation exposure (in uSv)(during coronary angiography)