Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiog… (NCT07380399) | Clinical Trial Compass
RecruitingNot Applicable
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty
Greece127 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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
Exclusion Criteria
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
Timeframe: 30 days
Trial details
NCT IDNCT07380399
SponsorNational and Kapodistrian University of Athens