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Distal vs Conventional Transradial Access for Coronary Procedures

Comparison of Distal and Conventional Transradial Access for Coronary Catheterization: A Multicenter, Quasi-Randomized Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07138170
Enrollment
350
Registered
2025-08-22
Start date
2025-08-15
Completion date
2026-04-29
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Artery Occlusion Following Coronary Catheterization

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.

Interventions

PROCEDUREConventional Transradial Artery Access

Using Conventional Transradial Artery Access for Cardiac Catheterization

Using Distal Radial Artery access for Cardiac Catheterization

Sponsors

Jordanian Research and Artificial Intelligence Group
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The ultrasound operator is blinded to the group of the patient.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. Undergoing diagnostic coronary angiography or percutaneous coronary intervention via an intended radial approach 3. Palpable radial pulse at the intended puncture site 4. Able to provide written or verbal informed consent 5. No contraindication to radial artery access at the intended site, as determined by the treating operator

Exclusion criteria

1. Age \< 18 years 2. Inability to provide informed consent 3. Absent or non-palpable radial pulse at the intended access site 4. Active pregnancy 5. Medical condition likely to cause non-compliance with the study protocol or confound data interpretation

Design outcomes

Primary

MeasureTime frameDescription
Radial artery occlusion (RAO) assessed by duplex ultrasonography24 hours and 1-6 months post procedureRadial artery occlusion defined as absence of antegrade flow on duplex ultrasonography, assessed within 24 hours and at 1-6 months after the procedure.

Secondary

MeasureTime frameDescription
Access-Site Pain24 hours and 1-6 months post-procedure.The patients will be asked to rate their pain on a 1-10 scale.
Crossover to Alternative Access SiteAt the time of procedureIn cases where radial access is unsuccessful, crossover to an alternative access site, such as the contralateral radial or femoral artery, will be documented
Access-Site Numbness24 hours and 1-6 months post-procedureNumber of participants with numbness at the access site assessed by physical examination.
Access-Site Bruising24 hours and 1-6 months post-procedureNumber of participants with bruising at the access site assessed by physical examination.

Countries

Jordan

Contacts

PRINCIPAL_INVESTIGATORMahmoud Izraiq, Medical Doctor

The Specialty Hospital

PRINCIPAL_INVESTIGATORRaed Aqel, Medical Doctor

Al-Mezan Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026