Clinical trial NCT00222430: Fluoroscopy Guided Femoral Arterial Access
Official title: Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access
Keywords: Fluoroscopy
Femoral Artery
Arterial Vascular Access
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 he/she 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

Eligibility criteria: Inclusion Criteria:

* Age 18 and over.
* Patients undergoing elective or urgent left heart cath from the femoral approach.
* Willingness to participate and sign the consent form.

Exclusion Criteria:

* Access from site other than the common femoral artery.
* Creatinine \>= 3.0mg/dl.
* Graft in the common femoral artery or other surgeries at that site that might have changed the anatomy of the groin.
* Unable or refusal to sign a consent form.
* Patients from the Department of Corrections.
* Pregnant Women
* Undetectable femoral artery pulse.
* Patients undergoing emergent cardiac catheterization for ST elevation MI or unstable ACS.

Primary outcomes:
measure: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
timeFrame: 24 hours
Secondary outcomes:
measure: Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
timeFrame: 24 hours
measure: Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
timeFrame: Intraprocedural
measure: Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.
timeFrame: Intraprocedural
measure: Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.
timeFrame: End of study analysis
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Thomas Hennebry, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Mazen S Abu-Fadel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abu-Fadel MS, Sparling JM, Zacharias SJ, Aston CE, Saucedo JF, Schechter E, Hennebry TA. Fluoroscopy vs. traditional guided femoral arterial access and the use of closure devices: a randomized controlled trial. Catheter Cardiovasc Interv. 2009 Oct 1;74(4):533-9. doi: 10.1002/ccd.22174.