Association Between Radial Artery Access Point and Radial Artery Spasm

NCT ID: NCT07060820

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2026-01-15

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.

Detailed Description

The transradial approach (TRA) is the standard vascular access route for diagnostic coronary angiography and percutaneous coronary interventions, in accordance with contemporary guidelines, due to lower bleeding risk, improved patient comfort, and facilitation of early mobilization compared with femoral access. Despite these advantages, radial artery spasm (RAS) remains a common and clinically relevant complication during transradial procedures, often associated with procedural difficulty, the need for access site crossover, and patient discomfort.

RAS is characterised by sudden, transient contraction of the radial artery during sheath insertion or catheter manipulation, which may result in difficulty in catheter advancement, and, in rare cases, procedural failure or catheter entrapment. Several clinical and procedural factors have been identified as being associated with the development of RAS, including female sex, smaller arterial diameter, use of larger sheaths, inadequate sedation, and limited operator experience. Currently radial access is recommended near the styloid process but there is limited data on the effects of different puncture distances from the styloid process on the development of RAS. We examined the impact of different radial artery puncture distances from the styloid process, on the development of radial artery spasm and access-site-related complications.

Conditions

Coronary Artery Disease; Radial Artery Spasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

0-20 mm Puncture Distance Group

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).

Group Type: EXPERIMENTAL

Radial Artery Puncture at 0-20 mm

Intervention Type: PROCEDURE

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).

21 mm Puncture Distance Group

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).

Group Type: EXPERIMENTAL

Radial Artery Puncture at >21 mm

Intervention Type: PROCEDURE

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).

Interventions

Radial Artery Puncture at 0-20 mm

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).

Intervention Type: PROCEDURE

Radial Artery Puncture at >21 mm

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin Medicalpark Hastanesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vedat ASLAN, MD

Role: PRINCIPAL_INVESTIGATOR

Toros University

Locations

VM Medicalpark Mersin Hospital

Mersin, Mezitli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MMP-KAR-VA-01

Identifier Type: -

Identifier Source: org_study_id