NCT00222430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
990

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

September 20, 2005

Last Update Submit

March 27, 2012

Conditions

Vascular Access

Keywords

FluoroscopyFemoral ArteryArterial Vascular Access

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Compare the incidence of known major side effects of femoral artery puncture between the two methods of access

    24 hours

  • Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.

    Intraprocedural

  • 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

  • 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

Study Arms (2)

A

ACTIVE COMPARATOR

Usual standard coronary angiographic procedure

Procedure: Active Comparator

B

EXPERIMENTAL

Fluoroscopy-guided coronary angiography

Procedure: Fluoroscopy

Interventions

FluoroscopyPROCEDURE

Use of fluoroscopy during arterial insertion of coronary catheter

B
Active ComparatorPROCEDURE

Standard coronary angiography technique; no fluoroscopic assistance

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related 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):533-9. doi: 10.1002/ccd.22174.

    PMID: 19626694RESULT

Related Links

Study Officials

  • Thomas Hennebry, M.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Mazen S Abu-Fadel, M.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(2)