Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222430
Status:
COMPLETED
Last Update Posted:
2012-03-28
First Post:
2005-09-20
Brief Title:
Fluoroscopy Guided Femoral Arterial Access
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-03
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 purpose of this study is to compare the use of fluoroscopic guidance a commonly used X-ray technique with the traditional approach where the doctors feel for the strongest pulse to obtain access to the blood vessel in the groin These two methods are being compared to assess which is faster safer and more often allows your physician to use an arterial closure device a small suture or plug applied at the end of the angiogram where the needle enters your blood vessel if heshe chooses
Detailed Description:
Design A prospective randomized controlled clinical trial to study the effectiveness of applying fluoroscopy guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site
Purpose To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices
Enrollment An approximate enrollment of up to 1000 patients all patients randomized who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City
Duration The study will be conducted over approximately one year
Primary Endpoint Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm
Secondary Endpoints
1 Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
2 Compare the time and number of attempts needed to obtain arterial access between the two groups of patients
3 Compare the ability to puncture the common femoral artery using fluoroscopy vs anatomical landmarks among different levels of trainees cardiology fellows and attending cardiologists
4 Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows
Analytical Subset Intention-to-treat sample
Purpose To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices
Enrollment An approximate enrollment of up to 1000 patients all patients randomized who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City
Duration The study will be conducted over approximately one year
Primary Endpoint Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm
Secondary Endpoints
1 Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
2 Compare the time and number of attempts needed to obtain arterial access between the two groups of patients
3 Compare the ability to puncture the common femoral artery using fluoroscopy vs anatomical landmarks among different levels of trainees cardiology fellows and attending cardiologists
4 Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows
Analytical Subset Intention-to-treat sample
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