Mersin Medicalpark hospital
Mersin, Mezitli, 33010, Turkey (Türkiye)
Location status: Recruiting
Location contact
Gökhan AVCI, MD
CONTACT
Sefa Sural, MD
CONTACT
Vedat ASLAN, MD
SUB_INVESTIGATOR
NCT Number: NCT07614386
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Mersin, Mezitli, 33010, Turkey (Türkiye)
Location status: Recruiting
Gökhan AVCI, MD
CONTACT
Sefa Sural, MD
CONTACT
Vedat ASLAN, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.
Time frame: Within 1 year after procedure
Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
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.
Time frame: During Procedure
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
Time frame: During procedure
Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
Time frame: During Procedure
Need for conversion from radial or ulnar access to another vascular access site during the procedure.
Time frame: During Procedure
Incidence of access-site or non-access-site bleeding complications following the procedure.
Time frame: During Procedure
Total fluoroscopy time during the procedure, measured in minutes.
Time frame: From the date of vascular intervention until hospital discharge, assessed up to 30 days
Duration of hospitalization following vascular intervention, measured in days from the date of the procedure until hospital discharge.
Time frame: During Procedure
Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
Contact information is provided by the study sponsor or research team.
Gökhan AVCI, MD
CONTACT
Sefa SURAL, MD
CONTACT
Mersin Medicalpark Hastanesi
Other
Radial Access Data in Vascular Interventions: A Prospective Observational Registry Study
Acronym: RADIUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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