Completed

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

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What is being tested

Trans-radial

+ Trans-femoral

Other
Who is being recruted

Cardiovascular Diseases+2

+ Heart Diseases

+ Vascular Diseases

Over 21 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorInstituto de Cardiologia do Rio Grande do Sul
Last updated: September 17, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01794325
Principal SponsorInstituto de Cardiologia do Rio Grande do Sul
Last updated: September 17, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Disease

Criteria

3 inclusion criteria required to participate
Accept to sign the written consent form (WCF)
Eligible for either transfemoral or transradial approach
Indication for a elective coronary angiography
5 exclusion criteria prevent from participating
Contraindication to perform both coronary and left ventricle angiogram
End stage renal failure
Necessity of another vascular angiogram during coronary angiography
Refusal to sign the WCF
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Coronary angiography performed through trans-radial access

Group II

Active Comparator
Coronary angiography performed through trans-femoral access

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, BrazilOpen Instituto de Cardiologia do Rio Grande do Sul in Google Maps
CompletedOne Study Center