Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01707524
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2012-10-12
Brief Title:
Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 failuredifficult These predictors include age 70 female gender height 64 inches and history of hypertensionThe 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 failuredifficulty 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
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 failuredifficulty 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None