Comparison of Distal and Proximal Radial Artery Patency Following Coronary Catheterization, A Real Look at a Special Community

NCT07138170 | Not Yet Recruiting

• 1 other identifier: RAPT
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Radial artery occlusion is the Achilles' heel of radial artery catheterization; this well-known complication is very serious, with an incidence ranging between 5-30% when using the proximal or anterior radial artery access. Emerging evidence suggests that distal radial access may preserve radial artery patency more effectively, with reported occlusion rates between one and two percent. Maintaining radial artery patency is crucial for future procedures, such as utilizing the radial artery as a conduit for CABG (Coronary Artery Bypass Grafting) or for shunts in dialysis patients. Objective: The aim of this study is to compare distal and proximal radial artery access in patients undergoing coronary catheterization by evaluating radial artery patency and complication rates at time zero(1-2 days post-procedure), and at 1-6 months post-procedure. This is the first randomized clinical trial of its kind conducted in Palestine and possibly the broader Middle East region, where resources are often very limited, which in turn will reflect a real look at some real communities' experiences. Methods: This randomized clinical trial will include 250 patients over eighteen years old who are scheduled for coronary catheterization. Participants will be randomly assigned either to proximal radial artery access or distal radial artery access. This approach created two equal groups: one group undergoing distal radial artery access and the other proximal radial artery access, with one hundred twenty-five patients in each group. Due to the nature of our practice in the two cardiac centers sharing in the study, all procedures will be performed by very experienced interventional cardiologists. Radial artery patency will be evaluated by a blinded ultrasound specialist at 1-2 days and at 1-6 months post-index procedure. Complication rates, including pain, bleeding, hematoma, and hand function, will also be assessed as secondary outcomes. In cases where radial access is unsuccessful, crossover to an alternative access site, such as the contralateral radial or femoral artery, will be documented. Expected Results: It is hypothesized that distal radial access will result in significantly lower rates of radial artery occlusion compared to proximal access across the two time points. Complication rates are also expected to be lower in the distal radial artery group.. Conclusion: This study may support the use of distal radial access as a preferred approach in coronary catheterization due to improved long-term radial artery patency, without an increase in access-related complications.

Conditions

Radial Artery Occlusion Following Coronary Catheterization

Outcome Measures

Primary Outcomes (1)

• Number of participants with Radial Artery occlusion

  1-2 days and 1-6 months post procedure

Secondary Outcomes (5)

• Number of participants with Pain

  1-2 days and 1-6 months post-procedure.

• Number of patients with bleeding

  1-2 days and 1-6 months post-procedure.

• Number of Participants with hematoma

  1-2 days and 1-6 months post-procedure.

• sensory and motor hand function

  1-2 days and 1-6 months post-procedure.

• Number of patients with unsuccessful radial access

  At the time of procedure

Study Arms (2)

Proximal Radial Artery Access Group

EXPERIMENTAL

Procedure: Proximal Radial Artery Access

Distal Radial Artery Access Group

EXPERIMENTAL

Procedure: Distal Radial Artery Access

Interventions

Proximal Radial Artery Access PROCEDURE

Using Proximal Radial Artery Access for Cardiac Catheterization

Proximal Radial Artery 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:

• Adults above the age of 18 years old and accepting participation in the study.

You may not qualify if:

• patients below the age of 18 or declined to participate in the study.

Sponsors & Collaborators

• Jordanian Research and Artificial Intelligence Group: lead

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

Central Study Contacts

Mahmoud Izraiq, Medical Doctor

CONTACT

+962795652260; izraiq@yahoo.com

Study Design

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

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: February 15, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share