Radial Access Data in Vascular Interventions Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMersin Medicalpark Hastanesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access

Ability to provide informed consent

Disqualifiers

Age <18 years

Procedures performed without radial or ulnar artery access

Incomplete procedural or clinical data

Refusal to participate in the registry

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radial and Ulnar Artery Access

    Procedure/Surgery

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

Treatment groups

20,000 Participants
are divided into 1 treatment group
Group A: Radial and Ulnar Access Registry Cohort1 intervention

Trial outcomes

Primary outcomes

1

Radial Artery Occlusion Rate

Incidence of radial artery occlusion following percutaneous vascular interventions performed via radial artery access.

Time frame
Within 1 year after procedure
2

Access-Site Vascular Complication Rate

Incidence of vascular access-site complications including bleeding, hematoma, pseudoaneurysm, arterial dissection, and vascular injury.

Time frame
through study completion, an average of 1 year
3

Radial Artery Spasm Rate

Incidence of clinically significant radial artery spasm during or immediately after the procedure.

Time frame
During Procedure

Secondary outcomes

1

Procedural Success Rate

Successful completion of the planned vascular intervention using radial or ulnar artery access without crossover to alternative access.

Time frame
During procedure
2

Crossover Rate

Need for conversion from radial or ulnar access to another vascular access site during the procedure.

Time frame
During Procedure
3

Bleeding Complications

Incidence of access-site or non-access-site bleeding complications following the procedure.

Time frame
During Procedure
4

Fluoroscopy Time

Total fluoroscopy time during the procedure, measured in minutes.

Time frame
During Procedure

Other outcomes

Sponsors and contacts

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