- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07614386
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sefa SURAL, MD
- Número de teléfono: +90 532 565 01 60
- Correo electrónico: sesural@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Gökhan AVCI, MD
- Número de teléfono: +90 506 228 57 09
- Correo electrónico: drgavci@hotmail.com
Ubicaciones de estudio
-
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Mezitli
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Mersin, Mezitli, Turquía (Türkiye), 33010
- Reclutamiento
- Mersin Medicalpark Hospital
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Contacto:
- Sefa Sural, MD
- Número de teléfono: +905325650160
- Correo electrónico: sesural@hotmail.com
-
Contacto:
- Gökhan AVCI, MD
- Correo electrónico: drgavci@gmail.com
-
Sub-Investigador:
- Vedat ASLAN, MD
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Radial and Ulnar Access Registry Cohort
Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.
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Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Radial Artery Occlusion Rate
Periodo de tiempo: Within 1 year after procedure
|
Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
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Within 1 year after procedure
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Access-Site Vascular Complication Rate
Periodo de tiempo: through study completion, an average of 1 year
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Incidence of vascular access-site complications including bleeding, hematoma, pseudoaneurysm, arterial dissection, and vascular injury.
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through study completion, an average of 1 year
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Radial Artery Spasm Rate
Periodo de tiempo: During Procedure
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Incidence of clinically significant radial artery spasm during or immediately after the procedure.
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During Procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedural Success Rate
Periodo de tiempo: During procedure
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Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
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During procedure
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Crossover Rate
Periodo de tiempo: During Procedure
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Need for conversion from radial or ulnar access to another vascular access site during the procedure.
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During Procedure
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Bleeding Complications
Periodo de tiempo: During Procedure
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Incidence of access-site or non-access-site bleeding complications following the procedure.
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During Procedure
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Fluoroscopy Time
Periodo de tiempo: During Procedure
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Total fluoroscopy time during the procedure, measured in minutes.
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During Procedure
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Length of Hospital Stay
Periodo de tiempo: From the date of vascular intervention until hospital discharge, assessed up to 30 days
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Duration of hospitalization following vascular intervention, measured in days from the date of the procedure until hospital discharge.
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From the date of vascular intervention until hospital discharge, assessed up to 30 days
|
|
Contrast Volume
Periodo de tiempo: During Procedure
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Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
|
During Procedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sefa SURAL, MD, Toros University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SRL-RADIUS-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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