Radial Artery OcclusionULNARTNCT07380399
Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty
An observational study of Radial Artery Occlusion and Vascular Access, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion, Vascular Access, Coronary Artery Disease (CAD)
- How many people
- 127 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Nov 2025to Jan 2032
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are recruited from cardiac catheterization laboratories and cardiology services of two tertiary-care public hospitals in Greece, including high-volume referral centers performing invasive coronary procedures. The study population represents adults undergoing routine elective coronary angiography or angioplasty in these hospital settings, where vascular access decisions are made as part of standard clinical practice.
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Local conditions at the intended access site, such as active infection, burn, or extensive scarring
- Pregnancy or breastfeeding
- Life expectancy less than 6 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Hellenic Red Cross Hospital
Athens
Dimitris Karelas, MD, +30 698 64 28463, dim.f.karelas@gmail.com
- Recruiting
Hippokratio General Hospital
Athens
Dimitris Karelas, MD, +30 698 6428463, dim.f.karelas@gmail.com
About this study
Official title: Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function (ULNART)
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.
Read more
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.
Read the detailed description
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.
The results of ULNART are expected to provide systematic evidence on the vascular safety and functional impact of transulnar access in patients with radial artery occlusion, supporting informed access-site selection and patient counseling when transradial access is unavailable or clinically undesirable.
- Keywords
- Radial Artery Occlusion, Ulnar Artery, Coronary Angiography, Percutaneous Coronary Intervention, Upper Limb Function, Transulnar Access
- Medical subject headings
- Arterial Occlusive Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
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.
Measured: 30 days
Secondary outcomes (10)
Number of Access Attempts
Number of puncture attempts required to obtain successful vascular access
Measured: During the index procedure
Technical Success Without Access-Site Crossover
Successful completion of coronary angiography or angioplasty via intended transulnar access without conversion to an alternative vascular access site.
Measured: During the index procedure
Procedure Duration
Total procedural time from vascular access to sheath removal
Measured: During the index procedure
Ulnar Artery Patency
Assessment of ulnar artery patency and flow characteristics using color duplex ultrasonography, including presence of antegrade flow and absence of occlusion or flow-limiting abnormalities.
Measured: Within 24 hours, 30 days, and 180 days
Early Access-Related Vascular and Neuromuscular Complications
Incidence of access-related vascular and neurologic complications occurring within 24 hours after removal of the hemostatic device, including minor bleeding, hematoma, reversible neurologic symptoms, and access-site findings not meeting criteria for the primary endpoint.
Measured: Within 24 hours after band removal
Change in Handgrip Strength
Change from baseline in handgrip strength of the access-side hand measured with a calibrated dynamometer.
Measured: Within 24 hours, 30 days, and 180 days
Change in Key Pinch Strength
Change from baseline in key (lateral) pinch strength of the access-side hand measured with a calibrated pinch gauge.
Measured: Within 24 hours, 30 days, and 180 days
Change in Sensory Function
Change from baseline in tactile sensation of the ulnar nerve distribution assessed using standardized light-touch threshold testing.
Measured: Within 24 hours, 30 days, and 180 days
Change in Patient-Reported Upper-Limb Function
Change from baseline in patient-reported upper-limb function assessed using validated questionnaires evaluating disability and cold sensitivity.
Measured: 10 days, 30 days and 180 days
Late Vascular or Neuromuscular Complications
Incidence of vascular or neurologic complications occurring beyond 30 days that do not meet primary endpoint criteria.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Nov 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karelas Dimitrios, National and Kapodistrian University of Athens
- Investigators
- Konstantinos Aznaouridis, Ass. Professor of Cardiology, Principal investigator, 1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of AthensDimitrios Karelas, MD, Principal investigator, National and Kapodistrian University of AthensIoannis Tsiafoutis, MD, PhD, Principal investigator, 2nd Department of Cardiology, Hellenic Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380399
- Sponsor's protocol ID
- 21171-01/12/2025
- Acronym
- ULNART
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications arising from this study will be made available, including demographic variables, procedural characteristics, vascular imaging findings, functional test results, and patient-reported outcome measures. A corresponding data dictionary and study protocol will be provided. Data will be shared after publication of the primary results, upon reasonable request, subject to approval by the study investigators and completion of a data-use agreement, in accordance with applicable ethical approvals and data protection regulations.
Publications
Roghani-Dehkordi F, Hosseinzadeh H, Kermani-Alghoraishi M, Khosravi A, Vakhshoori M, Sadeghi M, Danesh M, Sadeghi N, Sahfie D. The transulnar approach in the patients with ipsilateral radial artery occlusion. ARYA Atheroscler. 2020 Jan;16(1):33-38. doi: 10.22122/arya.v16i1.2016.
PubMed 32499829Hsueh SK, Cheng CI, Fang HY, Omran MM, Liu WH, Chung WJ, Chen CJ, Yang CH, Fang CY, Wu CJ. Feasibility and Safety of Transulnar Catheterization in Ipsilateral Radial Artery Occlusion. Int Heart J. 2017 May 31;58(3):313-319. doi: 10.1536/ihj.16-244. Epub 2017 May 12.
PubMed 28496021Kedev S, Zafirovska B, Dharma S, Petkoska D. Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E51-60. doi: 10.1002/ccd.25123. Epub 2013 Aug 5.
PubMed 23832623Duarte PVF, Cortes LA, de Almeida Sampaio FB, Barroso JM, da Silveira GM, Nascif GB, Filho AO, Ribeiro ML, Salles MM, De Lorenzo A. Feasibility and Safety of Ipsilateral Ulnar Access in Cases of Impossibility or Failure of Radial Access for Coronary Angiography or Percutaneous Coronary Intervention. J Invasive Cardiol. 2022 Feb;34(2):E92-E97. doi: 10.25270/jic/21.00138. Epub 2022 Jan 16.
PubMed 35037897Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
PubMed 31753298Hahalis G, Aznaouridis K, Tsigkas G, Davlouros P, Xanthopoulou I, Koutsogiannis N, Koniari I, Leopoulou M, Costerousse O, Tousoulis D, Bertrand OF. 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. J Am Heart Assoc. 2017 Aug 23;6(8):e005430. doi: 10.1161/JAHA.116.005430.
PubMed 28838915Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.
PubMed 35595672Zwaan EM, Cheung ES, IJsselmuiden AJJ, Holtzer CAJ, Schreuders TAR, Kofflard MJM, Coert JH. Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial. J Interv Cardiol. 2022 Sep 6;2022:6858962. doi: 10.1155/2022/6858962. eCollection 2022.
PubMed 36128073Valgimigli M, Campo G, Penzo C, Tebaldi M, Biscaglia S, Ferrari R; RADAR Investigators. Transradial coronary catheterization and intervention across the whole spectrum of Allen test results. J Am Coll Cardiol. 2014 May 13;63(18):1833-41. doi: 10.1016/j.jacc.2013.12.043. Epub 2014 Feb 26.
PubMed 24583305Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.
PubMed 29665617
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty: Safety and Effect on Hand Function (ULNART)
- ClinicalTrials.gov ID
- NCT07380399
- Acronym / sponsor ID
- ULNART / 21171-01/12/2025
- Keywords
- Radial Artery Occlusion, Ulnar Artery, Coronary Angiography, Percutaneous Coronary Intervention, Upper Limb Function, Transulnar Access
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The results of ULNART are expected to provide systematic evidence on the vascular safety and functional impact of transulnar access in patients with radial artery occlusion, supporting informed access-site selection and patient counseling when transradial access is unavailable or clinically undesirable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited from cardiac catheterization laboratories and cardiology services of two tertiary-care public hospitals in Greece, including high-volume referral centers performing invasive coronary procedures. The study population represents adults undergoing routine elective coronary angiography or angioplasty in these hospital settings, where vascular access decisions are made as part of standard clinical practice.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications
Time frame: 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.
10 secondary outcomes
Number of Access Attempts
Time frame: During the index procedure
Technical Success Without Access-Site Crossover
Time frame: During the index procedure
Procedure Duration
Time frame: During the index procedure
Ulnar Artery Patency
Time frame: Within 24 hours, 30 days, and 180 days
Early Access-Related Vascular and Neuromuscular Complications
Time frame: Within 24 hours after band removal
Change in Handgrip Strength
Time frame: Within 24 hours, 30 days, and 180 days
Change in Key Pinch Strength
Time frame: Within 24 hours, 30 days, and 180 days
Change in Sensory Function
Time frame: Within 24 hours, 30 days, and 180 days
Change in Patient-Reported Upper-Limb Function
Time frame: 10 days, 30 days and 180 days
Late Vascular or Neuromuscular Complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 32499829Roghani-Dehkordi F, Hosseinzadeh H, Kermani-Alghoraishi M, Khosravi A, Vakhshoori M, Sadeghi M, Danesh M, Sadeghi N, Sahfie D. The transulnar approach in the patients with ipsilateral radial artery occlusion. ARYA Atheroscler. 2020 Jan;16(1):33-38. doi: 10.22122/arya.v16i1.2016.
- Background: PubMed 28496021Hsueh SK, Cheng CI, Fang HY, Omran MM, Liu WH, Chung WJ, Chen CJ, Yang CH, Fang CY, Wu CJ. Feasibility and Safety of Transulnar Catheterization in Ipsilateral Radial Artery Occlusion. Int Heart J. 2017 May 31;58(3):313-319. doi: 10.1536/ihj.16-244. Epub 2017 May 12.
- Background: PubMed 23832623Kedev S, Zafirovska B, Dharma S, Petkoska D. Safety and feasibility of transulnar catheterization when ipsilateral radial access is not available. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):E51-60. doi: 10.1002/ccd.25123. Epub 2013 Aug 5.
- Background: PubMed 35037897Duarte PVF, Cortes LA, de Almeida Sampaio FB, Barroso JM, da Silveira GM, Nascif GB, Filho AO, Ribeiro ML, Salles MM, De Lorenzo A. Feasibility and Safety of Ipsilateral Ulnar Access in Cases of Impossibility or Failure of Radial Access for Coronary Angiography or Percutaneous Coronary Intervention. J Invasive Cardiol. 2022 Feb;34(2):E92-E97. doi: 10.25270/jic/21.00138. Epub 2022 Jan 16.
- Background: PubMed 31753298Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
- Background: PubMed 28838915Hahalis G, Aznaouridis K, Tsigkas G, Davlouros P, Xanthopoulou I, Koutsogiannis N, Koniari I, Leopoulou M, Costerousse O, Tousoulis D, Bertrand OF. 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. J Am Heart Assoc. 2017 Aug 23;6(8):e005430. doi: 10.1161/JAHA.116.005430.
- Background: PubMed 35595672Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.
- Background: PubMed 36128073Zwaan EM, Cheung ES, IJsselmuiden AJJ, Holtzer CAJ, Schreuders TAR, Kofflard MJM, Coert JH. Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial. J Interv Cardiol. 2022 Sep 6;2022:6858962. doi: 10.1155/2022/6858962. eCollection 2022.
- Background: PubMed 24583305Valgimigli M, Campo G, Penzo C, Tebaldi M, Biscaglia S, Ferrari R; RADAR Investigators. Transradial coronary catheterization and intervention across the whole spectrum of Allen test results. J Am Coll Cardiol. 2014 May 13;63(18):1833-41. doi: 10.1016/j.jacc.2013.12.043. Epub 2014 Feb 26.
- Background: PubMed 29665617Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications arising from this study will be made available, including demographic variables, procedural characteristics, vascular imaging findings, functional test results, and patient-reported outcome measures. A corresponding data dictionary and study protocol will be provided. Data will be shared after publication of the primary results, upon reasonable request, subject to approval by the study investigators and completion of a data-use agreement, in accordance with applicable ethical approvals and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos Aznaouridis, Ass. Professor of Cardiology principal investigator
1st Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens
Dimitrios Karelas, MD principal investigator
National and Kapodistrian University of Athens
Ioannis Tsiafoutis, MD, PhD principal investigator
2nd Department of Cardiology, Hellenic Red Cross Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery Occlusion and Vascular Access, run by National and Kapodistrian University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Karelas, MD (+30 698 6428463, dim.f.karelas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Access-Related Vascular and Clinical Neuromuscular Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380399, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.