NCT07060820

Brief Summary

This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Patients undergoing coronary angiography via radial access will be randomized into two groups based on the puncture site distance: 0-20 mm and \>21 mm from the styloid process. The procedure will be performed by experienced interventional cardiologists using standard techniques and medications. The primary goal is to determine if a specific puncture site reduces the incidence of RAS, which is a common complication during transradial procedures. The study will also record procedural details and monitor for other complications to identify the optimal puncture site for reducing RAS and improving patient comfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

July 2, 2025

Last Update Submit

January 17, 2026

Conditions

Keywords

Transradial AccessRadial Artery SpasmCoronary Angiography

Outcome Measures

Primary Outcomes (1)

  • Radial Artery Spasm during Transradial Coronary Angiography

    İnsidance of Radial Artery Spasm during Transradial Coronary Angiography

    During the procedure

Secondary Outcomes (1)

  • Incidence of access site complications

    Within 5 days post-procedure

Study Arms (2)

0-20 mm Puncture Distance Group

EXPERIMENTAL

Radial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS).

Procedure: Radial Artery Puncture at 0-20 mm

21 mm Puncture Distance Group

EXPERIMENTAL

Radial artery puncture performed 21-40 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS).

Procedure: Radial Artery Puncture at >21 mm

Interventions

Radial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).

0-20 mm Puncture Distance Group

Radial artery puncture performed at a distance greater than 21 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).

21 mm Puncture Distance Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and older. Patients scheduled for coronary angiography via transradial access. Patients with a palpable radial artery pulse. Patients with a normal Allen test.

You may not qualify if:

  • Abnormal Allen test results. Absence of palpable radial artery pulse. History of prior transradial coronary angiography with hemodynamic instability. Patients with severe comorbid conditions precluding safe participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VM Medicalpark Mersin Hospital

Mersin, Mezitli, 33200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Vedat ASLAN, MD

    Toros University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

July 3, 2025

Primary Completion

December 31, 2025

Study Completion

January 15, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study is a single-center observational procedural study with limited resources for external data sharing and monitoring. Data can be shared upon reasonable request to the principal investigator in compliance with local regulations.

Locations