Distal vs Conventional Transradial Access for Coronary Procedures

NCT07138170 | Completed

• 1 other identifier: RADIAL-REAL
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Radial artery occlusion (RAO) is a recognized complication of transradial coronary access, with reported incidence rates ranging from 5% to 30%. Distal radial access (DRA), performed at the anatomical snuffbox, has emerged as a promising alternative that may better preserve radial artery patency by maintaining antegrade perfusion through the palmar arch during hemostasis. Objective: To compare distal radial access with conventional transradial access in terms of radial artery patency and access-site outcomes in a real-world all-comers population undergoing coronary angiography or percutaneous coronary intervention. Methods: This prospective, multicenter, open-label, quasi-randomized comparative study enrolled 350 patients across three community-based hospitals in Palestine and Jordan between 2024 and 2026. Patients were allocated in a 1:1 ratio to DRA (n=183) or conventional transradial access (n=167) using an alternating sequence. The primary endpoint was radial artery patency assessed by blinded duplex ultrasonography at 24 hours and at 1 to 6 months. Secondary endpoints included access-site pain, bruising, numbness, and crossover to an alternative access site. The 24-hour outcome was analyzed by intention-to-treat and long-term outcomes by per-protocol analysis. Adjusted analyses used Firth penalized logistic regression.

Conditions

Radial Artery Occlusion Following Coronary Catheterization

Outcome Measures

Primary Outcomes (1)

• Radial artery occlusion (RAO) assessed by duplex ultrasonography

  Radial artery occlusion defined as absence of antegrade flow on duplex ultrasonography, assessed within 24 hours and at 1-6 months after the procedure.

  24 hours and 1-6 months post procedure

Secondary Outcomes (4)

• Access-Site Pain

  24 hours and 1-6 months post-procedure.

• Crossover to Alternative Access Site

  At the time of procedure

• Access-Site Numbness

  24 hours and 1-6 months post-procedure

• Access-Site Bruising

  24 hours and 1-6 months post-procedure

Study Arms (2)

Conventional Transradial Access Group

EXPERIMENTAL

Procedure: Conventional Transradial Artery Access

Distal Radial Artery Access Group

EXPERIMENTAL

Procedure: Distal Radial Artery Access

Interventions

Conventional Transradial Artery Access PROCEDURE

Using Conventional Transradial Artery Access for Cardiac Catheterization

Conventional Transradial Access Group

Distal Radial Artery Access PROCEDURE

Using Distal Radial Artery access for Cardiac Catheterization

Distal Radial Artery Access Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Undergoing diagnostic coronary angiography or percutaneous coronary intervention via an intended radial approach
• Palpable radial pulse at the intended puncture site
• Able to provide written or verbal informed consent
• No contraindication to radial artery access at the intended site, as determined by the treating operator

You may not qualify if:

• Age \< 18 years
• Inability to provide informed consent
• Absent or non-palpable radial pulse at the intended access site
• Active pregnancy
• Medical condition likely to cause non-compliance with the study protocol or confound data interpretation

Sponsors & Collaborators

• Jordanian Research and Artificial Intelligence Group: lead

Study Sites (1)

Specialty Hospital

Amman, Shmeisani, Jordan

Location

Related Publications (1)

• Sinha SK, Jha MJ, Mishra V, Thakur R, Goel A, Kumar A, Singh AK, Sachan M, Varma CM, Krishna V. Radial Artery Occlusion - Incidence, Predictors and Long-term outcome after TRAnsradial Catheterization: clinico-Doppler ultrasound-based study (RAIL-TRAC study). Acta Cardiol. 2017 Jun;72(3):318-327. doi: 10.1080/00015385.2017.1305158. Epub 2017 Mar 30.

  PMID: 28636520 BACKGROUND

Study Officials

• Mahmoud Izraiq, Medical Doctor

  The Specialty Hospital

  PRINCIPAL INVESTIGATOR

• Raed Aqel, Medical Doctor

  Al-Mezan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ultrasound operator is blinded to the group of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were allocated using an alternating sequence (quasi-randomized, non-concealed allocation), reflecting real-world practice.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 22, 2025
• Study Start: August 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: April 29, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)