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Radial Access Data in Vascular Interventions Registry (RADIUS)

18 juni 2026 bijgewerkt door: Mersin Medicalpark Hastanesi

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

20000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Mezitli
      • Mersin, Mezitli, Turkije (Türkiye), 33010
        • Werving
        • Mersin Medicalpark Hospital
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Vedat ASLAN, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radial Artery Occlusion Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: During Procedure
Incidence of clinically significant radial artery spasm during or immediately after the procedure.
During Procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Procedural Success Rate
Tijdsspanne: During procedure
Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.
During procedure
Crossover Rate
Tijdsspanne: During Procedure
Need for conversion from radial or ulnar access to another vascular access site during the procedure.
During Procedure
Bleeding Complications
Tijdsspanne: During Procedure
Incidence of access-site or non-access-site bleeding complications following the procedure.
During Procedure
Fluoroscopy Time
Tijdsspanne: During Procedure
Total fluoroscopy time during the procedure, measured in minutes.
During Procedure
Length of Hospital Stay
Tijdsspanne: 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
Tijdsspanne: During Procedure
Total volume of contrast agent administered during the procedure, measured in milliliters (mL).
During Procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Sefa SURAL, MD, Toros University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 mei 2026

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

20 mei 2031

Studieregistratiedata

Eerst ingediend

15 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to make individual participant data (IPD) publicly available.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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