Coronary angiography and angioplasty are commonly performed through the radial artery at the wrist as this approach is associated with fewer bleeding complications and faster recovery. In some patients, the radial artery becomes occluded after prior procedures, requiring selection of an alternative access site for future coronary interventions. The ulnar artery is a potential alternative wrist access. However, limited data are available on the safety of using the ulnar artery in the same arm as an occluded radial artery and on the possible effects on hand strength, sensation, and daily hand function. The goal of this observational study is to evaluate the safety of transulnar access and its effect on hand function in adults with ipsilateral radial artery occlusion undergoing coronary angiography or angioplasty. The main questions addressed by the study are: * How often do serious access-related vascular or nerve complications occur? * Does hand strength, sensation, or functional use of the hand change during follow-up? * Does the ulnar artery remain patent after the procedure? The choice of vascular access site is made by the treating physician based on clinical judgment. Participants who undergo transulnar access will undergo follow-up assessments, including ultrasound evaluation of arm arteries, standardized hand function testing, and short questionnaires assessing upper-limb function. The findings of this study are expected to inform access-site selection, improve patient counseling, and support safer care for patients with radial artery occlusion undergoing coronary procedures.
Transradial access is the preferred approach for coronary angiography and angioplasty because it is associated with reduced bleeding complications and faster recovery compared with femoral access. Radial artery occlusion is a recognized complication of transradial procedures and may limit future use of this access site. In patients with radial artery occlusion, selection of an alternative vascular access is required, particularly when preservation of the contralateral radial artery is clinically important. The ulnar artery represents an anatomically plausible alternative upper-limb access route, contributing substantially to hand perfusion through the palmar arterial network. However, concerns remain regarding the vascular and functional safety of transulnar access, especially when used ipsilateral to a pre-existing radial artery occlusion. Available evidence is limited and methodologically heterogeneous, with inconsistent assessment of vascular integrity and hand function. ULNART is a prospective observational cohort designed to evaluate the safety and functional outcomes of transulnar arterial access in patients with ipsilateral radial artery occlusion undergoing coronary angiography or angioplasty. Vascular access selection is determined by the treating physician and is not assigned by the study protocol. The study observes outcomes following transulnar access without influencing procedural decision-making. Participants undergo standardized baseline and follow-up assessments integrating vascular imaging, objective neuromuscular testing, and patient-reported outcome measures. Color duplex ultrasonography is used to assess upper-limb arterial anatomy and ulnar artery patency, while hand function is evaluated using quantitative strength testing, sensory assessment, and validated questionnaires addressing upper-limb function and cold sensitivity. Assessments are repeated shortly after the procedure and at predefined later time points to evaluate recovery and detect early or delayed access-related effects. The primary objective is to estimate the incidence of serious access-related vascular and clinical neuromuscular complications. Secondary objectives include characterization of ulnar artery patency, changes in hand strength and sensory function over time, patient-reported functional outcomes, and identification of factors associated with adverse events. Data are collected prospectively using standardized protocols and analyzed according to a prespecified statistical analysis plan appropriate for an observational cohort. The results of ULNART are expected to provide systematic evidence on the vascular safety and functional impact of transulnar access in patients with radial artery occlusion, supporting informed access-site selection and patient counseling when transradial access is unavailable or clinically undesirable.
Study Type
OBSERVATIONAL
Enrollment
127
Hellenic Red Cross Hospital
Athens, Greece
RECRUITINGHippokratio General Hospital
Athens, Greece
RECRUITINGIncidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
Composite incidence of serious vascular and clinical neuromuscular complications attributable to transulnar arterial access ipsilateral to radial artery occlusion. Serious vascular events include acute hand ischemia, symptomatic ulnar artery occlusion, flow-limiting dissection requiring treatment, pseudoaneurysm or arteriovenous fistula requiring intervention, major access-site hematoma, or major bleeding. Clinical neuromuscular events include new, clinically evident motor or sensory deficits in the ulnar nerve distribution that persist or require targeted therapy.
Time frame: 30 days
Number of Access Attempts
Number of puncture attempts required to obtain successful vascular access
Time frame: During the index procedure
Technical Success Without Access-Site Crossover
Successful completion of coronary angiography or angioplasty via intended transulnar access without conversion to an alternative vascular access site.
Time frame: During the index procedure
Procedure Duration
Total procedural time from vascular access to sheath removal
Time frame: During the index procedure
Ulnar Artery Patency
Assessment of ulnar artery patency and flow characteristics using color duplex ultrasonography, including presence of antegrade flow and absence of occlusion or flow-limiting abnormalities.
Time frame: Within 24 hours, 30 days, and 180 days
Early Access-Related Vascular and Neuromuscular Complications
Incidence of access-related vascular and neurologic complications occurring within 24 hours after removal of the hemostatic device, including minor bleeding, hematoma, reversible neurologic symptoms, and access-site findings not meeting criteria for the primary endpoint.
Time frame: Within 24 hours after band removal
Change in Handgrip Strength
Change from baseline in handgrip strength of the access-side hand measured with a calibrated dynamometer.
Time frame: Within 24 hours, 30 days, and 180 days
Change in Key Pinch Strength
Change from baseline in key (lateral) pinch strength of the access-side hand measured with a calibrated pinch gauge.
Time frame: Within 24 hours, 30 days, and 180 days
Change in Sensory Function
Change from baseline in tactile sensation of the ulnar nerve distribution assessed using standardized light-touch threshold testing.
Time frame: Within 24 hours, 30 days, and 180 days
Change in Patient-Reported Upper-Limb Function
Change from baseline in patient-reported upper-limb function assessed using validated questionnaires evaluating disability and cold sensitivity.
Time frame: 10 days, 30 days and 180 days
Late Vascular or Neuromuscular Complications
Incidence of vascular or neurologic complications occurring beyond 30 days that do not meet primary endpoint criteria.
Time frame: 6 months
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