Arterial Cannulation During Vascular ProceduresNCT01612026
Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients
An observational study of Arterial Cannulation During Vascular Procedures, run by CAMC Health System at 1 site in United States.
Trial summary
In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass graft puncture, and to ensure accurate… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Cannulation During Vascular Procedures
- What is being tested?
- arterial cannulation by angiographic imaging
- Type of treatment
- Surgery or procedure
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects referred to the West Virginia University Department of Surgery: Division of Vascular and Endovascular Surgery with accepted indications to undergo a catheter-based diagnostic or interventional procedure requiring arterial cannulation.Procedures include peripheral, renal, mesenteric and carotid.
Who may be able to join
- Patients greater than 18 years of age undergoing a non-cardiac catheter-based diagnostic or interventional procedure requiring femoral artery cannulation. This will include patients with co-morbid conditions of coronary artery disease and other cardiac health problems.
Who cannot join
- Patients less than 18 years of age.
- Patients enrolled in another IRB approved biomedical study.
- Pregnant females.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vascular Center of Excellence
Charleston, West Virginia, 25304
About this study
In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass graft puncture, and to ensure accurate arterial puncture in patients expected to receive large doses of blood-thinning medications during or after the procedure. For those practitioners experienced with ultrasound-guided access techniques, it is considered highly accurate and easy to use; thus, some physicians routinely use this tool. A well-designed study is needed to truly assess the accuracy of the ultrasound technique and to determine whether it may reduce complications of arterial access in vascular patients.
By demonstrating the safest, most accurate and efficient technique for obtaining arterial access during catheter-based procedures, the investigators could significantly reduce morbidity and mortality associated with complications of arterial puncture. Length of hospital stay, management costs and patient discomfort could be reduced by minimizing complication rates.
Read the detailed description
Arterial access accounts for the highest frequency of complications in catheter-based procedures in the U.S. In our vascular practice, ultrasound-guidance is frequently used in patients with weak or absent pulses, known aberrant vascular anatomy, need for graft puncture, and to ensure accurate arterial puncture in patients expected to receive large doses of anti-thrombotic medications. Some practitioners routinely use this modality. The purpose of this study is to determine whether real-time ultrasound guidance is superior to fluoroscopic guidance in obtaining successful arterial cannulation during diagnostic and interventional catheter-based procedures in a primarily non-cardiac vascular patient population. Patients will be randomized to receive either real-time ultrasound-guided arterial access or fluoroscopic-guided access. Baseline patient demographics, co-morbidities, medications, pertinent laboratory data, and indications for procedure will be recorded. Procedural data recorded will include procedure type, type of access, operator, pulse quality, sheath size, closure device, angiographic data for access artery, antithrombotic medications used, and intra-procedural activated clotting times. Primary endpoint will be successful arterial cannulation by angiographic imaging. Secondary end points will be time to access, number of attempts, accidental venipunctures, first pass success, complication rates and hospital length of stay. Data regarding complications (patient history, examination, laboratory or imaging studies) will be included for a period of 90 days after the procedure.
- Being tested
- arterial cannulation by angiographic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial cannulation by angiographic imagingProcedure or surgery
comparing successful arterial cannulation in case of non-cardiac vascular patient population.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Not described Receives: Procedure: arterial cannulation by angiographic imaging | |
| Fluoroscopy | Not described Receives: Procedure: arterial cannulation by angiographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups.
Measured: within 30 days
Secondary outcomes (1)
Number of attempts, accidental venipunctures, first pass success, complications for arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups.
Measured: within 30 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionOct 2017
- Study completionOct 2017
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 Arterial Cannulation During Vascular ProceduresStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Stone, M.D., Principal investigator, CAMC Medical Staff-with admitting privileges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612026
- Sponsor's protocol ID
- 1997155
- Status last verified
- May 2019
- First submitted
- 23 May 2012
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Stone P, Campbell J, Thompson S, Walker J. A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients. J Vasc Surg. 2020 Jul;72(1):259-267. doi: 10.1016/j.jvs.2019.09.051. Epub 2020 Jan 21.
PubMed 31980242
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients
- ClinicalTrials.gov ID
- NCT01612026
- Acronym / sponsor ID
- 1997155
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Jun 2012 (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.
In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass graft puncture, and to ensure accurate arterial puncture in patients expected to receive large doses of blood-thinning medications during or after the procedure. For those practitioners experienced with ultrasound-guided access techniques, it is considered highly accurate and easy to use; thus, some physicians routinely use this tool. A well-designed study is needed to truly assess the accuracy of the ultrasound technique and to determine whether it may reduce complications of arterial access in vascular patients.
By demonstrating the safest, most accurate and efficient technique for obtaining arterial access during catheter-based procedures, the investigators could significantly reduce morbidity and mortality associated with complications of arterial puncture. Length of hospital stay, management costs and patient discomfort could be reduced by minimizing complication rates.
Detailed description
Arterial access accounts for the highest frequency of complications in catheter-based procedures in the U.S. In our vascular practice, ultrasound-guidance is frequently used in patients with weak or absent pulses, known aberrant vascular anatomy, need for graft puncture, and to ensure accurate arterial puncture in patients expected to receive large doses of anti-thrombotic medications. Some practitioners routinely use this modality. The purpose of this study is to determine whether real-time ultrasound guidance is superior to fluoroscopic guidance in obtaining successful arterial cannulation during diagnostic and interventional catheter-based procedures in a primarily non-cardiac vascular patient population. Patients will be randomized to receive either real-time ultrasound-guided arterial access or fluoroscopic-guided access. Baseline patient demographics, co-morbidities, medications, pertinent laboratory data, and indications for procedure will be recorded. Procedural data recorded will include procedure type, type of access, operator, pulse quality, sheath size, closure device, angiographic data for access artery, antithrombotic medications used, and intra-procedural activated clotting times. Primary endpoint will be successful arterial cannulation by angiographic imaging. Secondary end points will be time to access, number of attempts, accidental venipunctures, first pass success, complication rates and hospital length of stay. Data regarding complications (patient history, examination, laboratory or imaging studies) will be included for a period of 90 days after the procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | Procedure: arterial cannulation by angiographic imaging |
| Fluoroscopy | – | Procedure: arterial cannulation by angiographic imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to the West Virginia University Department of Surgery: Division of Vascular and Endovascular Surgery with accepted indications to undergo a catheter-based diagnostic or interventional procedure requiring arterial cannulation.Procedures include peripheral, renal, mesenteric and carotid.
Key inclusion criteria (1 listed)
- Patients greater than 18 years of age undergoing a non-cardiac catheter-based diagnostic or interventional procedure requiring femoral artery cannulation. This will include patients with co-morbid conditions of coronary artery disease and other cardiac health problems.
Key exclusion criteria (4 listed)
- Patients less than 18 years of age.
- Patients enrolled in another IRB approved biomedical study.
- Pregnant females.
- Prisoners.
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 |
|---|---|---|
| arterial cannulation by angiographic imagingcomparing successful arterial cannulation in case of non-cardiac vascular patient population. | Procedure or surgery | Fluoroscopy, Ultrasound |
Primary outcome
Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups.
Time frame: within 30 days
1 secondary outcome
Number of attempts, accidental venipunctures, first pass success, complications for arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups.
Time frame: within 30 to 90 days
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 18 Aug 2026.
- Results publication: PubMed 31980242Stone P, Campbell J, Thompson S, Walker J. A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients. J Vasc Surg. 2020 Jul;72(1):259-267. doi: 10.1016/j.jvs.2019.09.051. Epub 2020 Jan 21.
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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.
Patrick Stone, M.D. principal investigator
CAMC Medical Staff-with admitting privileges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Cannulation During Vascular Procedures, run by CAMC Health System at 1 site 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 1 inclusion and 4 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups. (time frame: within 30 days). 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 NCT01612026, 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 18 Aug 2026.