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

Официальное название

Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function (ULNART)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications [Срок оценки: 30 days]

Вторичные конечные точки (10)

• Number of Access Attempts [Срок оценки: During the index procedure]
• Technical Success Without Access-Site Crossover [Срок оценки: During the index procedure]
• Procedure Duration [Срок оценки: During the index procedure]
• Ulnar Artery Patency [Срок оценки: Within 24 hours, 30 days, and 180 days]
• Early Access-Related Vascular and Neuromuscular Complications [Срок оценки: Within 24 hours after band removal]
• Change in Handgrip Strength [Срок оценки: Within 24 hours, 30 days, and 180 days]
• Change in Key Pinch Strength [Срок оценки: Within 24 hours, 30 days, and 180 days]
• Change in Sensory Function [Срок оценки: Within 24 hours, 30 days, and 180 days]
• Change in Patient-Reported Upper-Limb Function [Срок оценки: 10 days, 30 days and 180 days]
• Late Vascular or Neuromuscular Complications [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 2 центра

• Hellenic Red Cross Hospital — Athens
• Hippokratio General Hospital — Athens

Публикации

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• Hsueh SK, Cheng CI, Fang HY, Omran MM, Liu WH, Chung WJ, Chen CJ, Yang CH, Fang CY, Wu CJ. Feasibility and Safety of Transulnar Catheterization in Ipsilateral Radial Artery Occlusion. Int Heart J. 2017 May 31;58(3):313-319. doi: 10.1536/ihj.16-244. Epub 2017 May 12. PMID 28496021
• Kedev S, Zafirovska B, Dharma S, Petkoska D. Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E51-60. doi: 10.1002/ccd.25123. Epub 2013 Aug 5. PMID 23832623
• Duarte PVF, Cortes LA, de Almeida Sampaio FB, Barroso JM, da Silveira GM, Nascif GB, Filho AO, Ribeiro ML, Salles MM, De Lorenzo A. Feasibility and Safety of Ipsilateral Ulnar Access in Cases of Impossibility or Failure of Radial Access for Coronary Angiography or Percutaneous Coronary Intervention. J Invasive Cardiol. 2022 Feb;34(2):E92-E97. doi: 10.25270/jic/21.00138. Epub 2022 Jan 16. PMID 35037897
• Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC C PMID 31753298
• Hahalis G, Aznaouridis K, Tsigkas G, Davlouros P, Xanthopoulou I, Koutsogiannis N, Koniari I, Leopoulou M, Costerousse O, Tousoulis D, Bertrand OF. Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis. J Am Heart Assoc. 2017 Aug 23;6(8):e005430. doi: 1 PMID 28838915
• Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17. PMID 35595672
• Zwaan EM, Cheung ES, IJsselmuiden AJJ, Holtzer CAJ, Schreuders TAR, Kofflard MJM, Coert JH. Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial. J Interv Cardiol. 2022 Sep 6;2022:6858962. doi: 10.1155/2022/6858962. eCollection 2022. PMID 36128073

Идентификаторы

NCT: NCT07380399 · 21171-01/12/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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