Vascular AccessNCT00222430
Fluoroscopy Guided Femoral Arterial Access
A study testing Fluoroscopy and Active Comparator in people with Vascular Access, run by University of Oklahoma at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access
- What is being tested?
- Fluoroscopy and Active Comparator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over.
- Patients undergoing elective or urgent left heart cath from the femoral approach.
- Willingness to participate and sign the consent form.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.
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.
Read the 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:
- Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
- Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
- Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.
- 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
- Conditions
- Vascular Access
- Being tested
- Fluoroscopy, Active Comparator
- Keywords
- Fluoroscopy, Femoral Artery, Arterial Vascular Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyProcedure or surgery
Use of fluoroscopy during arterial insertion of coronary catheter
Active ComparatorProcedure or surgery
Standard coronary angiography technique; no fluoroscopic assistance
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Usual standard coronary angiographic procedure Receives: Procedure: Active Comparator |
| B | Experimental | Fluoroscopy-guided coronary angiography Receives: Procedure: Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
Measured: 24 hours
Secondary outcomes (4)
Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
Measured: 24 hours
Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
Measured: 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.
Measured: Intraprocedural
Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.
Measured: End of study analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Hennebry, M.D., Principal investigator, University of OklahomaMazen S Abu-Fadel, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222430
- Sponsor's protocol ID
- 11854
- Status last verified
- Mar 2012
- First submitted
- 20 Sep 2005
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19626694
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00222430
- Acronym / sponsor ID
- 11854
- Conditions
- Vascular Access
- Keywords
- Fluoroscopy, Femoral Artery, Arterial Vascular Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
- Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
- Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Active ComparatorUsual standard coronary angiographic procedure |
| B | Experimental | Procedure: FluoroscopyFluoroscopy-guided coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and over.
- Patients undergoing elective or urgent left heart cath from the femoral approach.
- Willingness to participate and sign the consent form.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoroscopyUse of fluoroscopy during arterial insertion of coronary catheter | Procedure or surgery | B |
| Active ComparatorStandard coronary angiography technique; no fluoroscopic assistance | Procedure or surgery | A |
Primary outcome
Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.
Time frame: 24 hours
4 secondary outcomes
Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
Time frame: 24 hours
Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
Time frame: 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.
Time frame: Intraprocedural
Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.
Time frame: End of study analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Results publication: PubMed 19626694Abu-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hennebry, M.D. principal investigator
University of Oklahoma
Mazen S Abu-Fadel, M.D. principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy and Active Comparator in people with Vascular Access, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2012.