- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Sefa SURAL, MD
- Telefonní číslo: +90 532 565 01 60
- E-mail: sesural@hotmail.com
Studijní záloha kontaktů
- Jméno: Gökhan AVCI, MD
- Telefonní číslo: +90 506 228 57 09
- E-mail: drgavci@hotmail.com
Studijní místa
-
-
Mezitli
-
Mersin, Mezitli, Turecko (Türkiye), 33010
- Nábor
- Mersin Medicalpark hospital
-
Kontakt:
- Sefa Sural, MD
- Telefonní číslo: +905325650160
- E-mail: sesural@hotmail.com
-
Kontakt:
- Gökhan AVCI, MD
- E-mail: drgavci@gmail.com
-
Dílčí vyšetřovatel:
- Vedat ASLAN, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Radial Artery Occlusion Rate
Časové okno: 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
Časové okno: 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
Časové okno: During Procedure
|
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
|
During Procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Procedural Success Rate
Časové okno: During procedure
|
Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
|
During procedure
|
|
Crossover Rate
Časové okno: During Procedure
|
Need for conversion from radial or ulnar access to another vascular access site during the procedure.
|
During Procedure
|
|
Bleeding Complications
Časové okno: During Procedure
|
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
Časové okno: During Procedure
|
Total fluoroscopy time during the procedure, measured in minutes.
|
During Procedure
|
|
Length of Hospital Stay
Časové okno: 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
Časové okno: During Procedure
|
Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
|
During Procedure
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Sefa SURAL, MD, Toros University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SRL-RADIUS-001
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Popis plánu IPD
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Klinické studie na Radial and Ulnar Artery Access
-
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