Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors (EXPERT)

I

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems