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Radial Access Data in Vascular Interventions Registry

Radial Access Data in Vascular Interventions: A Prospective Observational Registry Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07614386
Acronym
RADIUS
Enrollment
20000
Registered
2026-05-29
Start date
2026-05-15
Completion date
2031-05-20
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Peripheral Arterial Disease, Radial Artery Occlusion, Radial Artery Spasm, Vascular Access Complications

Keywords

Radial access, Ulnar access, Transradial intervention, Coronary angiography, Percutaneous coronary intervention, Vascular complications, Radial artery occlusion, Radial Artery Spasm, Registry

Brief 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 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.

Interventions

PROCEDURERadial and Ulnar Artery Access

Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.

Sponsors

Mersin Medicalpark Hastanesi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radial Artery Occlusion RateWithin 1 year after procedureIncidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
Access-Site Vascular Complication Ratethrough study completion, an average of 1 yearIncidence of vascular access-site complications including bleeding, hematoma, pseudoaneurysm, arterial dissection, and vascular injury.
Radial Artery Spasm RateDuring ProcedureIncidence of clinically significant radial artery spasm during or immediately after the procedure.

Secondary

MeasureTime frameDescription
Procedural Success RateDuring procedureSuccessful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
Crossover RateDuring ProcedureNeed for conversion from radial or ulnar access to another vascular access site during the procedure.
Bleeding ComplicationsDuring ProcedureIncidence of access-site or non-access-site bleeding complications following the procedure.
Fluoroscopy TimeDuring ProcedureTotal fluoroscopy time during the procedure, measured in minutes.
Length of Hospital StayFrom the date of vascular intervention until hospital discharge, assessed up to 30 daysDuration of hospitalization following vascular intervention, measured in days from the date of the procedure until hospital discharge.
Contrast VolumeDuring ProcedureTotal volume of contrast agent administered during the procedure, measured in milliliters (mL).

Countries

Turkey (Türkiye)

Contacts

CONTACTSefa SURAL, MD
sesural@hotmail.com+90 532 565 01 60
CONTACTGökhan AVCI, MD
drgavci@hotmail.com+90 506 228 57 09
STUDY_DIRECTORSefa SURAL, MD

Toros University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026