Fluoroscopy Guided Femoral Arterial Access

Vascular Access Clinical Trial

Official title:

Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222430
• Other study ID #: 11854
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: March 27, 2012
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Access

Intervention

Procedure:
• Fluoroscopy
Use of fluoroscopy during arterial insertion of coronary catheter
• Active Comparator
Standard coronary angiography technique; no fluoroscopic assistance

Locations

Country	Name	City	State
United States	University of Oklahoma Medical Center	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.		24 hours	Yes
Secondary	Compare the incidence of known major side effects of femoral artery puncture between the two methods of access		24 hours	Yes
Secondary	Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.		Intraprocedural	No
Secondary	Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.		Intraprocedural	No
Secondary	Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.		End of study analysis	No

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