Coronary Artery Disease (CAD), Radial Artery Occlusion, Vascular Access
Conditions
Keywords
Radial Artery Occlusion, Ulnar Artery, Coronary Angiography, Percutaneous Coronary Intervention, Upper Limb Function, Transulnar Access
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria to be eligible: * Adults aged 18 years or older * Documented radial artery occlusion in the upper limb intended for vascular access, confirmed by ultrasound or angiography * Scheduled to undergo elective coronary angiography and/or angioplasty * Transulnar arterial access on the same side as the occluded radial artery is selected by the treating physician * Contralateral radial artery access is not feasible or is clinically undesirable, including for reasons such as: * documented occlusion or severe disease of the contralateral radial artery * unfavorable anatomy or prior failed access * strategic preservation of the contralateral radial artery for future surgical or dialysis needs * Adequate ulnar artery flow and anatomy for access, as assessed by pre-procedural ultrasound * Able and willing to provide written informed consent
Exclusion criteria
Participants meeting any of the following criteria will be excluded: * Inadequate or absent ulnar artery flow at the intended access site on ultrasound * Known ulnar nerve injury or neuropathy affecting the access-side upper limb * Severe pre-existing motor or sensory dysfunction of the access-side hand that would interfere with functional assessment * Emergency coronary procedures that preclude baseline vascular or functional assessment * Participation in another interventional clinical study involving vascular access or intervention in the same upper limb * Local conditions at the intended access site, such as active infection, burn, or extensive scarring * Pregnancy or breastfeeding * Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Access Attempts | During the index procedure | Number of puncture attempts required to obtain successful vascular access |
| Technical Success Without Access-Site Crossover | During the index procedure | Successful completion of coronary angiography or angioplasty via intended transulnar access without conversion to an alternative vascular access site. |
| Procedure Duration | During the index procedure | Total procedural time from vascular access to sheath removal |
| Ulnar Artery Patency | Within 24 hours, 30 days, and 180 days | 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. |
| Early Access-Related Vascular and Neuromuscular Complications | Within 24 hours after band removal | 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. |
| Change in Handgrip Strength | Within 24 hours, 30 days, and 180 days | Change from baseline in handgrip strength of the access-side hand measured with a calibrated dynamometer. |
| Change in Key Pinch Strength | Within 24 hours, 30 days, and 180 days | Change from baseline in key (lateral) pinch strength of the access-side hand measured with a calibrated pinch gauge. |
| Change in Sensory Function | Within 24 hours, 30 days, and 180 days | Change from baseline in tactile sensation of the ulnar nerve distribution assessed using standardized light-touch threshold testing. |
| Change in Patient-Reported Upper-Limb Function | 10 days, 30 days and 180 days | Change from baseline in patient-reported upper-limb function assessed using validated questionnaires evaluating disability and cold sensitivity. |
| Late Vascular or Neuromuscular Complications | 6 months | Incidence of vascular or neurologic complications occurring beyond 30 days that do not meet primary endpoint criteria. |
Countries
Greece
Contacts
CONTACTDimitrios Karelas, MD
CONTACTKonstantinos Aznaouridis, Ass. Professor of Cardiology
PRINCIPAL_INVESTIGATORKonstantinos Aznaouridis, Ass. Professor of Cardiology
1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens
PRINCIPAL_INVESTIGATORDimitrios Karelas, MD
National and Kapodistrian University of Athens
PRINCIPAL_INVESTIGATORIoannis Tsiafoutis, MD, PhD
2nd Department of Cardiology, Hellenic Red Cross Hospital
Outcome results
None listed