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

Jordanian Research and Artificial Intelligence Group

Status: Not yet enrolling

Conditions: Radial Artery Occlusion Following Coronary Catheterization

Treatments: Procedure: Distal Radial Artery Access; Procedure: Proximal Radial Artery Access

Study type: Interventional

Funder types: Other

Identifiers

NCT07138170

RAPT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Proximal Radial Artery Access Group

Experimental group

Treatment:

Procedure: Proximal Radial Artery Access

Distal Radial Artery Access Group

Experimental group

Treatment:

Procedure: Distal Radial Artery Access