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Recruiting NCT07380399

NCT07380399 Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty

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Clinical Trial Summary
NCT ID NCT07380399
Status Recruiting
Phase —
Sponsor National and Kapodistrian University of Athens
Condition Radial Artery Occlusion
Study Type OBSERVATIONAL
Enrollment 127 participants
Start Date 2025-11-01
Primary Completion 2030-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 127 participants in total. It began in 2025-11-01 with a primary completion date of 2030-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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 * Local conditions at the intended access site, such as active infection, burn, or extensive scarring * Pregnancy or breastfeeding * Life expectancy less than 6 months

Contact & Investigator

Central Contact

Dimitrios Karelas, MD

✉ dim.f.karelas@gmail.com

📞 +30 698 6428463

Principal Investigator

Konstantinos Aznaouridis, Ass. Professor of Cardiology

PRINCIPAL INVESTIGATOR

1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens

Frequently Asked Questions

Who can join the NCT07380399 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Radial Artery Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07380399 currently recruiting?

Yes, NCT07380399 is actively recruiting participants. Contact the research team at dim.f.karelas@gmail.com for enrollment information.

Where is the NCT07380399 trial being conducted?

This trial is being conducted at Athens, Greece, Athens, Greece.

Who is sponsoring the NCT07380399 clinical trial?

NCT07380399 is sponsored by National and Kapodistrian University of Athens. The principal investigator is Konstantinos Aznaouridis, Ass. Professor of Cardiology at 1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens. The trial plans to enroll 127 participants.

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