Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants are recruited from cardiac catheterization laboratories and cardiology services of two tertiary-care public hospitals in Greece, including high-volume referral centers performing invasive coronary procedures. The study population represents adults undergoing routine elective coronary angiography or angioplasty in these hospital settings, where vascular access decisions are made as part of standard clinical practice.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

127 Participants
are grouped into 1 trial group
Group A: ULNART Cohort

Trial outcomes

Primary outcomes

1

Incidence 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

Secondary outcomes

1

Number of Access Attempts

Number of puncture attempts required to obtain successful vascular access

Time frame
During the index procedure
2

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
3

Procedure Duration

Total procedural time from vascular access to sheath removal

Time frame
During the index procedure
4

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

Other outcomes

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