Radial Access Data in Vascular Interventions Registry (RADIUS)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Radial Artery Occlusion; Vascular Access Complications; Radial Artery Spasm
• Intervention / Treatment: Procedure: Radial and Ulnar Artery Access

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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Sefa SURAL, MD; Phone Number: +90 532 565 01 60; Email: sesural@hotmail.com
• Study Contact Backup: Name: Gökhan AVCI, MD; Phone Number: +90 506 228 57 09; Email: drgavci@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.

Description

Inclusion Criteria:

• Age ≥18 years
• Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access
• Ability to provide informed consent

Exclusion Criteria:

• Age <18 years
• Procedures performed without radial or ulnar artery access
• Incomplete procedural or clinical data
• Refusal to participate in the registry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radial and Ulnar Access Registry Cohort; Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.	Procedure: Radial and Ulnar Artery Access; Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Occlusion Rate	Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.	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.	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.	During Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success Rate	Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.	During procedure
Crossover Rate	Need for conversion from radial or ulnar access to another vascular access site during the procedure.	During Procedure
Bleeding Complications	Incidence of access-site or non-access-site bleeding complications following the procedure.	During Procedure
Fluoroscopy Time	Total fluoroscopy time during the procedure, measured in minutes.	During Procedure
Length of Hospital Stay	Duration of hospitalization following vascular intervention, measured in days from the date of the procedure until hospital discharge.	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).	During Procedure

Collaborators and Investigators

• Sponsor: Mersin Medicalpark Hastanesi
• Investigators: Study Director: Sefa SURAL, MD, Toros University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2031

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Coronary angiography; Percutaneous coronary intervention; Registry; Radial artery occlusion; Radial access; Radial Artery Spasm; Vascular complications; Ulnar access; Transradial intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Peripheral Arterial Disease; Coronary Artery Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: SRL-RADIUS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No