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NCT Number: NCT01707524

Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure

The aim of this study is to measure radiation exposure during coronary angiography (CA) with a trans-radial approach (TRA), specifically comparing access via the left versus right radial artery in patients with suggested clinical predictors of TRA failure/difficult. These predictors include age >70, female gender, height <64 inches, and history of hypertension.The study also aims to determine difficulties encountered during left or right radial access in this specific patient population. A secondary aim is to compare the results of enrolled patients with a registry of patients where femoral access was obtained.

Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the United States annually. There is a growing trend to perform procedures utilizing the TRA due to recent data demonstrating decreased bleeding and access-site complications compared to the femoral approach. However, the TRA approach is also know to be associated with greater radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization may be difficult in certain populations because of anatomic considerations. Though traditionally completed via canalization of the right radial artery (RRA) due to feasibility with room setup, left radial artery (LRA) access may be superior due to the shorter distance needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian artery. Given the benefits of the TRA, it is important to determine how left versus right radial artery access affects parameters of radiation exposure in addition to procedural difficulty.

This study will be a prospective, randomized study of patients with suggested predictors of TRA failure/difficulty referred for coronary angiography. Patients referred for coronary angiography using the trans-radial approach will be randomly assigned to obtain arterial access via the right or left radial artery. A registry of patients referred for coronary angiography using the trans-femoral approach will be compiled. The primary outcome measure will be radiation exposure as measured by dose area product output from the coronary angiography system. Secondary measures will include the total fluoroscopy time, total dose of radiation, number of catheters used, and incidence of subclavian tortuosity. In addition, procedural complications and success rates will also be evaluated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients referred for cardiac catheterization procedure with 3 out of the following 4 characteristics: age ≥70 years, female gender, hypertensive, and ≤64 inches in height.

Exclusion criteria

Patients will be excluded if they 1) underwent prior CABG with utilization of an internal mammary artery, 2) have an abnormal Allen test, 3) require emergency cardiac catheterization, 4) are planned to undergo a staged PCI procedure, 5) do not consent or are unable to give consent, or 6) are participating in another competing study.

Treatment and study plan

Randomized left versus right radial artery approach

Procedure

Randomized left versus right radial artery approach

Primary outcomes

  1. Dose area product

    Time frame: During coronary angiography

Secondary outcomes

  1. total fluoroscopy time

    Time frame: during coronary angiography and PCI

  2. total radiation dose

    Time frame: during coronary angiography and PCI

  3. number of catheters used

    Time frame: during coronary angiography

  4. incidence of subclavian tortuosity

    Time frame: during coronary angiography

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure

Important dates

Study start
2012
Primary completion
2015
First posted
Oct 16, 2012
Registry last updated
Sep 24, 2015

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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