Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors (EXPERT)

Instituto de Cardiologia do Rio Grande do Sul

Status: Completed

Conditions: Coronary Heart Disease; Exposure to Ionizing Radiation; Vascular Access Complication

Treatments: Other: Trans-radial; Other: Trans-femoral

Study type: Interventional

Funder types: Other

Identifiers

NCT01794325

UP 4786/12

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Trans-radial access

Active Comparator group

Description:

Coronary angiography performed through trans-radial access

Treatment:

Other: Trans-radial

Trans-femoral access

Active Comparator group

Description:

Coronary angiography performed through trans-femoral access

Treatment:

Other: Trans-femoral