Coronary AngiographyNCT03794687
The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)
An observational study of Coronary Angiography, run by University of Florida at 1 site in United States.
Trial summary
The study team aims to perform a prospective observational case series of one hundred consecutive distal radial artery heart catheterizations to evaluate the safety and feasibility of distal radial access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Left heart catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to 15 Sep 2021
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of up to one hundred consecutive patients undergoing left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb) will be collected.
Who may be able to join
- Patients scheduled to undergo diagnostic left heart catheterization with or without percutaneous coronary intervention.
Who cannot join
- Hemodynamically unstable (on vasopressor continuous infusion, on mechanical support) patients.
- Patients undergoing emergent left heart catheterization for ST-elevation myocardial infarction.
- Full oral anticoagulation defined as use of a direct oral anticoagulant (DOAC) within 24 hours or an INR over 2.0 the day of the procedure.
- Active bleeding or known history of blood dyscrasia or bleeding diathesis.
- History of ipsilateral arteriovenous fistula or vascular surgical intervention.
- Patients unable to undergo distal radial artery access due to anatomical deformities, limited mobility, or other.
Trial locations and contacts
1 site in 1 country.
About this study
The study team aims to perform a prospective observational case series of one hundred consecutive distal radial artery heart catheterizations to evaluate the safety and feasibility of distal radial access. Distal radial artery access has evolved in the past few years as an alternative to the standard radial artery access for coronary angiography and interventions. However, the available data on the distal radial artery access for coronary angiography and interventions is limited to case reports and small retrospective case series. To date, no prospective randomized data is available. Therefore, the investigators aim to perform a prospective observational case series of one hundred sequential left heart catheterizations performed via distal radial artery to evaluate the safety and feasibility of the distal radial artery access.
Read the detailed description
Despite the abundance of data supporting the use of the radial artery compared to the femoral artery, data on the use the distal radial access site in the anatomical snuffbox is limited. Most of the available literature on the distal radial access comes from case reports and small retrospective case series looking primarily at the feasibility and success rates with this approach (4-6). Crossover rate from proximal radial to femoral approach in a prior randomized controlled trial was reported at 3.7% (2). A similar rate has been reported in case series studies of distal radial access, with success rates ranging from 88.6% to 96.3% (4-6). No cases of radial artery occlusion, hematoma, or hand paresthesia were reported in any of these series. Given the promising results with the distal radial approach, its use has expanded to many cardiac catheterization laboratories across the country. However, prospective randomized data comparing distal versus the conventional proximal radial arterial access sites is warranted.
Therefore, the aim of this study is to compile a prospective observational case series to evaluate the safety and feasibility of distal radial artery access in a prospective case series. If an acceptable safety profile can be demonstrated, the case series will be followed with a randomized controlled trial directly comparing distal to standard proximal radial artery approach.
Specific Aims and study hypothesis:
The primary aim of the present study is to assess the safety and feasibility of distal radial arterial access. The study hypothesis is that distal radial access for coronary angiography is associated with similar incidence rates of access site related complications compared to complication rates previously reported with the standard proximal radial artery access.
- Conditions
- Coronary Angiography
- Being tested
- Left heart catheterization
- Keywords
- Left heart catheterizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left heart catheterizationProcedure or surgery
Catheterization via the distal radial artery
| Study group | Role | What they receive |
|---|---|---|
| Distal Radial Artery | Left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb). Receives: Procedure: Left heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of distal radial arterial access
Incidence of any radial access complication defined as the composite of radial artery occlusion, radial artery vasospasm, other access site related bleeding or vascular complications, or hand dysfunction
Measured: 10 Minutes
Secondary outcomes (2)
Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.
Failure of access will be defined as inability to obtain access within 10 minutes from initial administration of local anesthetic to successful cannulation of the radial artery.
Measured: 10 Minutes
Patient satisfaction
Patient satisfaction will be assessed with a patient satisfaction survey following the procedure
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start3 Apr 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andres Pineda Maldonado, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794687
- Sponsor's protocol ID
- IRB201802924
- Status last verified
- Oct 2023
- First submitted
- 3 Jan 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)
- ClinicalTrials.gov ID
- NCT03794687
- Acronym / sponsor ID
- IRB201802924
- Conditions
- Coronary Angiography
- Keywords
- Left heart catheterizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 7 Jan 2019 (actual)
- 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 study team aims to perform a prospective observational case series of one hundred consecutive distal radial artery heart catheterizations to evaluate the safety and feasibility of distal radial access. Distal radial artery access has evolved in the past few years as an alternative to the standard radial artery access for coronary angiography and interventions. However, the available data on the distal radial artery access for coronary angiography and interventions is limited to case reports and small retrospective case series. To date, no prospective randomized data is available. Therefore, the investigators aim to perform a prospective observational case series of one hundred sequential left heart catheterizations performed via distal radial artery to evaluate the safety and feasibility of the distal radial artery access.
Detailed description
Despite the abundance of data supporting the use of the radial artery compared to the femoral artery, data on the use the distal radial access site in the anatomical snuffbox is limited. Most of the available literature on the distal radial access comes from case reports and small retrospective case series looking primarily at the feasibility and success rates with this approach (4-6). Crossover rate from proximal radial to femoral approach in a prior randomized controlled trial was reported at 3.7% (2). A similar rate has been reported in case series studies of distal radial access, with success rates ranging from 88.6% to 96.3% (4-6). No cases of radial artery occlusion, hematoma, or hand paresthesia were reported in any of these series. Given the promising results with the distal radial approach, its use has expanded to many cardiac catheterization laboratories across the country. However, prospective randomized data comparing distal versus the conventional proximal radial arterial access sites is warranted.
Therefore, the aim of this study is to compile a prospective observational case series to evaluate the safety and feasibility of distal radial artery access in a prospective case series. If an acceptable safety profile can be demonstrated, the case series will be followed with a randomized controlled trial directly comparing distal to standard proximal radial artery approach.
Specific Aims and study hypothesis:
The primary aim of the present study is to assess the safety and feasibility of distal radial arterial access. The study hypothesis is that distal radial access for coronary angiography is associated with similar incidence rates of access site related complications compared to complication rates previously reported with the standard proximal radial artery access.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal Radial Artery | – | Procedure: Left heart catheterizationLeft heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of up to one hundred consecutive patients undergoing left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb) will be collected.
Key inclusion criteria (1 listed)
- Patients scheduled to undergo diagnostic left heart catheterization with or without percutaneous coronary intervention.
Key exclusion criteria (6 listed)
- Hemodynamically unstable (on vasopressor continuous infusion, on mechanical support) patients.
- Patients undergoing emergent left heart catheterization for ST-elevation myocardial infarction.
- Full oral anticoagulation defined as use of a direct oral anticoagulant (DOAC) within 24 hours or an INR over 2.0 the day of the procedure.
- Active bleeding or known history of blood dyscrasia or bleeding diathesis.
- History of ipsilateral arteriovenous fistula or vascular surgical intervention.
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 |
|---|---|---|
| Left heart catheterizationCatheterization via the distal radial artery | Procedure or surgery | Distal Radial Artery |
Primary outcome
Safety of distal radial arterial access
Time frame: 10 Minutes
Incidence of any radial access complication defined as the composite of radial artery occlusion, radial artery vasospasm, other access site related bleeding or vascular complications, or hand dysfunction
2 secondary outcomes
Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.
Time frame: 10 Minutes
Patient satisfaction
Time frame: 30 Minutes
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 23 Oct 2023.
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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.
Andres Pineda Maldonado, MD principal investigator
University of Florida
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 Coronary Angiography, run by University of Florida 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 6 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 23 Oct 2023. 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?
Safety of distal radial arterial access (time frame: 10 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.