Radial Artery OcclusionRADIUSNCT07614386
Radial Access Data in Vascular Interventions Registry
An observational study of Radial Artery Occlusion and Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
The RADIUS study is a prospective observational registry designed to collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions. The study aims to evaluate procedural characteristics, access-site complications, procedural success, and short-term clinical outcomes associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion, Radial Artery Spasm, Vascular Access Complications
- What is being tested?
- Radial and Ulnar Artery Access
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 20 May 2031
- How long will I take part?
- 1 Year
- 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: Adult patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.
Who may be able to join
- Age ≥18 years
- Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access
- Ability to provide informed consent
Who cannot join
- Age <18 years
- Procedures performed without radial or ulnar artery access
- Incomplete procedural or clinical data
- Refusal to participate in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin Medicalpark hospital
Mersin, Mezitli, 33010
Sefa Sural, MD, +905325650160, sesural@hotmail.com
Gökhan AVCI, MD, drgavci@gmail.com
About this study
Official title: Radial Access Data in Vascular Interventions: A Prospective Observational Registry Study
The RADIUS study is a prospective observational registry designed to collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions. The study aims to evaluate procedural characteristics, access-site complications, procedural success, and short-term clinical outcomes associated with transradial and transulnar vascular access.
Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access at Mersin Medical Park Hospital will be consecutively enrolled. Demographic, clinical, angiographic, procedural, and post-procedural data will be prospectively collected and analyzed.
Read more
The study was initially designed as a single-center registry; however, following Institutional Review Board (IRB) approval, expansion into a multicenter registry with participating centers is planned.
This study is observational in nature and does not involve any experimental treatment, device, or intervention beyond standard clinical care.
Read the detailed description
The RADIUS (Radial Access Data in Vascular Interventions) study is a prospective observational registry designed to systematically collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions.
Transradial access has become increasingly preferred in contemporary interventional practice because of lower bleeding risk, improved patient comfort, earlier mobilization, and reduced vascular complications compared with traditional femoral access. In addition, transulnar access has emerged as an alternative vascular access strategy in selected patients. Despite the increasing adoption of radial and ulnar access techniques, comprehensive real-world registry data evaluating procedural characteristics, vascular complications, procedural success, and clinical outcomes remain limited.
The RADIUS registry aims to evaluate demographic, clinical, angiographic, procedural, and post-procedural characteristics of patients undergoing percutaneous vascular interventions through radial or ulnar artery access. Particular focus will be placed on access-site complications, including radial artery spasm, radial artery occlusion, bleeding complications, crossover to alternative access sites, vascular injury, and short-term clinical outcomes.
The study will enroll consecutive adult patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access at Mersin Medical Park Hospital between May 2026 and May 2031. Data will be prospectively collected from procedural reports, hospital electronic medical records, and routine clinical evaluations.
Collected variables will include demographic characteristics, cardiovascular risk factors, comorbidities, laboratory findings, angiographic and procedural details, vascular access characteristics, procedural duration, fluoroscopy time, contrast volume, devices and techniques used during procedures, procedural success rates, and in-hospital and short-term complications.
The study was initially designed as a single-center registry; however, expansion into a multicenter registry involving additional participating centers is planned following Institutional Review Board (IRB) approval and local regulatory processes.
This registry is purely observational in nature and does not involve any experimental drug, device, or intervention beyond standard clinical care. All procedures and treatment strategies will be performed according to current routine clinical practice and operator discretion.
Data obtained from the registry will be analyzed using appropriate statistical methods, and the results are expected to contribute to the understanding and optimization of radial and ulnar access strategies in vascular interventions and support future scientific publications.
- Conditions
- Radial Artery Occlusion, Radial Artery Spasm, Vascular Access Complications, Coronary Artery Disease, Peripheral Arterial Disease
- Being tested
- Radial and Ulnar Artery Access
- Keywords
- Radial access, Ulnar access, Transradial intervention, Coronary angiography, Percutaneous coronary intervention, Vascular complications, Radial artery occlusion, Radial Artery Spasm, Registry
- Medical subject headings
- Arterial Occlusive Diseases, Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial and Ulnar Artery AccessProcedure or surgery
Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Radial and Ulnar Access Registry Cohort | Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access. Receives: Procedure: Radial and Ulnar Artery Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Occlusion Rate
Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
Measured: Within 1 year after procedure
Access-Site Vascular Complication Rate
Incidence of vascular access-site complications including bleeding, hematoma, pseudoaneurysm, arterial dissection, and vascular injury.
Measured: through study completion, an average of 1 year
Radial Artery Spasm Rate
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
Measured: During Procedure
Secondary outcomes (6)
Procedural Success Rate
Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
Measured: During procedure
Crossover Rate
Need for conversion from radial or ulnar access to another vascular access site during the procedure.
Measured: During Procedure
Bleeding Complications
Incidence of access-site or non-access-site bleeding complications following the procedure.
Measured: During Procedure
Fluoroscopy Time
Total fluoroscopy time during the procedure, measured in minutes.
Measured: During Procedure
Length of Hospital Stay
Duration of hospitalization following vascular intervention, measured in days from the date of the procedure until hospital discharge.
Measured: From the date of vascular intervention until hospital discharge, assessed up to 30 days
Contrast Volume
Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 May 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion20 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- 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
- 20,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mersin Medicalpark Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sefa SURAL, MD, Study director, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614386
- Sponsor's protocol ID
- SRL-RADIUS-001
- Acronym
- RADIUS
- Status last verified
- Jun 2026
- First submitted
- 15 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Access Data in Vascular Interventions: A Prospective Observational Registry Study
- ClinicalTrials.gov ID
- NCT07614386
- Acronym / sponsor ID
- RADIUS / SRL-RADIUS-001
- Conditions
- Radial Artery Occlusion, Radial Artery Spasm, Vascular Access Complications, Coronary Artery Disease, Peripheral Arterial Disease
- Keywords
- Radial access, Ulnar access, Transradial intervention, Coronary angiography, Percutaneous coronary intervention, Vascular complications, Radial artery occlusion, Radial Artery Spasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Mersin Medicalpark HastanesiUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 20 May 2031 (estimated)
- First posted
- 29 May 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.
The RADIUS study is a prospective observational registry designed to collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions. The study aims to evaluate procedural characteristics, access-site complications, procedural success, and short-term clinical outcomes associated with transradial and transulnar vascular access.
Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access at Mersin Medical Park Hospital will be consecutively enrolled. Demographic, clinical, angiographic, procedural, and post-procedural data will be prospectively collected and analyzed.
The study was initially designed as a single-center registry; however, following Institutional Review Board (IRB) approval, expansion into a multicenter registry with participating centers is planned.
This study is observational in nature and does not involve any experimental treatment, device, or intervention beyond standard clinical care.
Detailed description
The RADIUS (Radial Access Data in Vascular Interventions) study is a prospective observational registry designed to systematically collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions.
Transradial access has become increasingly preferred in contemporary interventional practice because of lower bleeding risk, improved patient comfort, earlier mobilization, and reduced vascular complications compared with traditional femoral access. In addition, transulnar access has emerged as an alternative vascular access strategy in selected patients. Despite the increasing adoption of radial and ulnar access techniques, comprehensive real-world registry data evaluating procedural characteristics, vascular complications, procedural success, and clinical outcomes remain limited.
The RADIUS registry aims to evaluate demographic, clinical, angiographic, procedural, and post-procedural characteristics of patients undergoing percutaneous vascular interventions through radial or ulnar artery access. Particular focus will be placed on access-site complications, including radial artery spasm, radial artery occlusion, bleeding complications, crossover to alternative access sites, vascular injury, and short-term clinical outcomes.
The study will enroll consecutive adult patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access at Mersin Medical Park Hospital between May 2026 and May 2031. Data will be prospectively collected from procedural reports, hospital electronic medical records, and routine clinical evaluations.
Collected variables will include demographic characteristics, cardiovascular risk factors, comorbidities, laboratory findings, angiographic and procedural details, vascular access characteristics, procedural duration, fluoroscopy time, contrast volume, devices and techniques used during procedures, procedural success rates, and in-hospital and short-term complications.
The study was initially designed as a single-center registry; however, expansion into a multicenter registry involving additional participating centers is planned following Institutional Review Board (IRB) approval and local regulatory processes.
This registry is purely observational in nature and does not involve any experimental drug, device, or intervention beyond standard clinical care. All procedures and treatment strategies will be performed according to current routine clinical practice and operator discretion.
Data obtained from the registry will be analyzed using appropriate statistical methods, and the results are expected to contribute to the understanding and optimization of radial and ulnar access strategies in vascular interventions and support future scientific publications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radial and Ulnar Access Registry Cohort | – | Procedure: Radial and Ulnar Artery AccessPatients undergoing routine percutaneous vascular interventions via radial or ulnar artery access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Age <18 years
- Procedures performed without radial or ulnar artery access
- Incomplete procedural or clinical data
- Refusal to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial and Ulnar Artery AccessRoutine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice. | Procedure or surgery | Radial and Ulnar Access Registry Cohort |
Primary outcome
Radial Artery Occlusion Rate
Time frame: Within 1 year after procedure
Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
Access-Site Vascular Complication Rate
Time frame: through study completion, an average of 1 year
Incidence of vascular access-site complications including bleeding, hematoma, pseudoaneurysm, arterial dissection, and vascular injury.
Radial Artery Spasm Rate
Time frame: During Procedure
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
6 secondary outcomes
Procedural Success Rate
Time frame: During procedure
Crossover Rate
Time frame: During Procedure
Bleeding Complications
Time frame: During Procedure
Fluoroscopy Time
Time frame: During Procedure
Length of Hospital Stay
Time frame: From the date of vascular intervention until hospital discharge, assessed up to 30 days
Contrast Volume
Time frame: During Procedure
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 23 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) publicly available.
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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.
Sefa SURAL, MD study director
Toros University
1 site 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 Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Sefa SURAL, MD (+90 532 565 01 60, sesural@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial Artery Occlusion Rate (time frame: Within 1 year after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.