Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function (ULNART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ULNART Cohort
Adults with documented radial artery occlusion undergoing elective coronary angiography or angioplasty, in whom transulnar arterial access ipsilateral to the occluded radial artery is selected by the treating physician. Participants are followed prospectively to assess vascular safety and hand function outcomes.
结局指标
主要结局
Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
时间窗: 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.
次要结局
- Number of Access Attempts(During the index procedure)
- Technical Success Without Access-Site Crossover(During the index procedure)
- Procedure Duration(During the index procedure)
- Ulnar Artery Patency(Within 24 hours, 30 days, and 180 days)
- Early Access-Related Vascular and Neuromuscular Complications(Within 24 hours after band removal)
- Change in Handgrip Strength(Within 24 hours, 30 days, and 180 days)
- Change in Key Pinch Strength(Within 24 hours, 30 days, and 180 days)
- Change in Sensory Function(Within 24 hours, 30 days, and 180 days)
- Change in Patient-Reported Upper-Limb Function(10 days, 30 days and 180 days)
- Late Vascular or Neuromuscular Complications(6 months)
研究者
Karelas Dimitrios
Principal Investigator
National and Kapodistrian University of Athens