- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Sefa SURAL, MD
- Номер телефона: +90 532 565 01 60
- Электронная почта: sesural@hotmail.com
Учебное резервное копирование контактов
- Имя: Gökhan AVCI, MD
- Номер телефона: +90 506 228 57 09
- Электронная почта: drgavci@hotmail.com
Места учебы
-
-
Mezitli
-
Mersin, Mezitli, Турция (Туркие), 33010
- Рекрутинг
- Mersin Medicalpark Hospital
-
Контакт:
- Sefa Sural, MD
- Номер телефона: +905325650160
- Электронная почта: sesural@hotmail.com
-
Контакт:
- Gökhan AVCI, MD
- Электронная почта: drgavci@gmail.com
-
Младший исследователь:
- Vedat ASLAN, MD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Radial and Ulnar Access Registry Cohort
Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access.
|
Routine percutaneous vascular interventions performed via radial or ulnar artery access according to standard clinical practice.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Radial Artery Occlusion Rate
Временное ограничение: Within 1 year after procedure
|
Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.
|
Within 1 year after procedure
|
|
Access-Site Vascular Complication Rate
Временное ограничение: through study completion, an average of 1 year
|
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
Временное ограничение: During Procedure
|
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
|
During Procedure
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Procedural Success Rate
Временное ограничение: During procedure
|
Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
|
During procedure
|
|
Crossover Rate
Временное ограничение: During Procedure
|
Need for conversion from radial or ulnar access to another vascular access site during the procedure.
|
During Procedure
|
|
Bleeding Complications
Временное ограничение: During Procedure
|
Incidence of access-site or non-access-site bleeding complications following the procedure.
|
During Procedure
|
|
Fluoroscopy Time
Временное ограничение: During Procedure
|
Total fluoroscopy time during the procedure, measured in minutes.
|
During Procedure
|
|
Length of Hospital Stay
Временное ограничение: 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.
|
From the date of vascular intervention until hospital discharge, assessed up to 30 days
|
|
Contrast Volume
Временное ограничение: During Procedure
|
Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
|
During Procedure
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Sefa SURAL, MD, Toros University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SRL-RADIUS-001
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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