NCT07614386

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started May 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2031

First Submitted

Initial submission to the registry

May 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2031

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

4.6 years

First QC Date

May 15, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Radial accessUlnar accessTransradial interventionCoronary angiographyPercutaneous coronary interventionVascular complicationsRadial artery occlusionRadial Artery SpasmRegistry

Outcome Measures

Primary Outcomes (3)

  • Radial Artery Occlusion Rate

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

    Within 1 year after procedure

  • Access-Site Vascular Complication Rate

    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

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

    During Procedure

Secondary Outcomes (6)

  • Procedural Success Rate

    During procedure

  • Crossover Rate

    During Procedure

  • Bleeding Complications

    During Procedure

  • Fluoroscopy Time

    During Procedure

  • Length of Hospital Stay

    From the date of vascular intervention until hospital discharge, assessed up to 30 days

  • +1 more secondary outcomes

Study Arms (1)

Radial and Ulnar Access Registry Cohort

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

Procedure: Radial and Ulnar Artery Access

Interventions

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

Radial and Ulnar Access Registry Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age ≥18 years
  • Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access
  • Ability to provide informed consent

You may not qualify if:

  • Age \<18 years
  • Procedures performed without radial or ulnar artery access
  • Incomplete procedural or clinical data
  • Refusal to participate in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Medicalpark hospital

Mersin, Mezitli, 33010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive DiseasesCoronary Artery DiseasePeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisAtherosclerosisPeripheral Vascular Diseases

Study Officials

  • Sefa SURAL, MD

    Toros University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 29, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

May 20, 2031

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations