The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32209
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients scheduled to undergo diagnostic left heart catheterization with or without percutaneous coronary intervention.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Distal Radial Artery
Left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb).
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Catheterization via the distal radial artery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
10 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
10 Minutes
|
|
Patient satisfaction
Time Frame: 30 Minutes
|
Patient satisfaction will be assessed with a patient satisfaction survey following the procedure
|
30 Minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andres Pineda Maldonado, MD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201802924
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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