Safety and Hand Function After Transulnar Artery Access in Adults with Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty
Led by National and Kapodistrian University of Athens · Updated on 2026-02-02
127
Participants Needed
2
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects on hand function of using the ulnar artery for coronary angiography or angioplasty in adults who have a blocked radial artery on the same arm. This observational study focuses on patients with radial artery occlusion requiring an alternative access site and aims to understand complications, changes in hand strength and sensation, and artery patency over time.
Participants undergo coronary procedures with transulnar arterial access selected by their doctor. The study does not assign treatment but observes patients who receive transulnar access, following them with ultrasound exams of arm arteries, objective tests of hand strength and sensation, and questionnaires about hand function. Assessments are done before, shortly after, and at several points up to six months post-procedure.
During the study, participants will have ultrasound imaging, quantitative neuromuscular testing, sensory evaluations, and surveys to monitor recovery and detect any complications. The main measure is the rate of serious vascular or nerve complications within 30 days. Secondary measures include procedure details, artery patency at various times, changes in hand strength and sensation, patient-reported hand function, and late complications up to six months. The findings aim to support safer care and guide access site decisions for patients with radial artery occlusion.
CONDITIONS
Brief Title
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty
Research Team
D
Dimitrios Karelas, MD
K
Konstantinos Aznaouridis, Ass. Professor of Cardiology
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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 documented occlusion, severe disease, unfavorable anatomy, prior failed access, or strategic preservation for future needs
Adequate ulnar artery flow and anatomy for access, as assessed by pre-procedural ultrasound
Able and willing to provide written informed consent
You will not qualify if you...
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 interfering 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 day before the procedure
Participants undergo baseline assessments including vascular imaging and hand function testing to evaluate suitability and establish pre-procedure status.
1 visit (in-person)
Monitoring
Duration - During the procedure and up to 24 hours after
Participants are observed during and immediately after coronary angiography or angioplasty using transulnar arterial access, with assessments for vascular safety and hand function.
1 procedure visit and 1 follow-up visit within 24 hours
Long-term Monitoring
Duration - Up to 6 months
Participants undergo follow-up assessments to evaluate ulnar artery patency, hand strength, sensory function, and patient-reported outcomes to detect early and delayed effects.
Visits at approximately 10 days, 30 days, and 6 months post-procedure
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Study of Erectile Function Changes After Coronary Intervention in Men With Heart Attack or Stable Angina
Comparing Intravascular Ultrasound-Guided and Experienced Angiography-Guided Stenting
for Left Main Coronary Artery Bifurcation Lesions
A Prospective Randomized Clinical Trial
Phase 2a Study of SRSD107 Given by Injection in Adults With Chronic Coronary or Peripheral Arterial Disease
AI Facial Image Analysis to Screen for Coronary Artery Disease in Adults at High Risk from Community Settings
Study of AI-assisted Cardiac CT to Improve Risk Prediction and Outcomes in Adults with Coronary Artery Disease
Using Wearable Devices to Monitor and Predict Cardiovascular Health and Disease Risk in Adults
Comparison of Drug-Coated Balloon and Drug-Eluting Stent Strategies for High-Risk Coronary Artery Disease Patients Undergoing PCI
Bern Registry Comparing Intracoronary Optical Coherence Tomography and Coronary CT Angiography for Coronary Artery Disease
Observational Study of Three-Vessel Ultrasonic Flow Ratio to Predict Heart Events in Coronary Artery Disease Patients
Comparing Drug-Coated Balloons and Drug-Eluting Stents for Treating Chronic Total Blockages in Coronary Arteries A Multicenter Randomized Trial
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Feasibility and Safety of Ipsilateral Ulnar Access in Cases of Impossibility or Failure of Radial Access for Coronary Angiography or Percutaneous Coronary Intervention.
Paulo Vinicios Falcão Duarte, Leandro Assunção Cortes, Fernanda Barbosa de Almeida Sampaio...
Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper.
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.
George Hahalis, Konstantinos Aznaouridis, Gregory Tsigkas...
Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease.
Ahmed A Kolkailah, Rabah S Alreshq, Ahmed M Muhammed...