The transulnar approach in the patients with ipsilateral radial artery occlusion.
Farshad Roghani-Dehkordi, Hossein Hosseinzadeh, Mohammad Kermani-Alghoraishi...
https://pubmed.ncbi.nlm.nih.gov/32499829Actively Recruiting
Age: 18Years +
All Genders
ID07380399
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function
Led by National and Kapodistrian University of Athens · Updated on 2026-02-02
127
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 2 locations
1
Hellenic Red Cross Hospital
Athens, Greece
Actively Recruiting
2
Hippokratio General Hospital
Athens, Greece
Actively Recruiting
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Research Team
D
Dimitrios Karelas, MD
K
Konstantinos Aznaouridis, Ass. Professor of Cardiology
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
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Published Research Related To This Trial
Feasibility and Safety of Transulnar Catheterization in Ipsilateral Radial Artery Occlusion.
Shu-Kai Hsueh, Cheng-I Cheng, Hsiu-Yu Fang...
https://pubmed.ncbi.nlm.nih.gov/28496021Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available.
Sasko Kedev, Biljana Zafirovska, Surya Dharma...
https://pubmed.ncbi.nlm.nih.gov/23832623Feasibility 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...
https://pubmed.ncbi.nlm.nih.gov/35037897Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper.
Ivo Bernat, Adel Aminian, Samir Pancholy...
https://pubmed.ncbi.nlm.nih.gov/31753298Radial 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...
https://pubmed.ncbi.nlm.nih.gov/28838915International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study.
Gregory A Sgueglia, Ahmed Hassan, Stefan Harb...
https://pubmed.ncbi.nlm.nih.gov/35595672Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial.
Eva M Zwaan, Elena S Cheung, Alexander J J IJsselmuiden...
https://pubmed.ncbi.nlm.nih.gov/36128073Transradial coronary catheterization and intervention across the whole spectrum of Allen test results.
Marco Valgimigli, Gianluca Campo, Carlo Penzo...
https://pubmed.ncbi.nlm.nih.gov/24583305Transradial 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...
https://pubmed.ncbi.nlm.nih.gov/29665617