Radial Artery Occlusion Following Coronary CatheterizationNCT07138170
Distal vs Conventional Transradial Access for Coronary Procedures
A study testing Conventional Transradial Artery Access and Distal Radial Artery Access in people with Radial Artery Occlusion Following Coronary Catheterization, run by Jordanian Research and Artificial Intelligence Group at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion Following Coronary Catheterization
- What is being tested?
- Conventional Transradial Artery Access and Distal Radial Artery Access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteJordan
- Study dates
- 15 Aug 2025to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Distal and Conventional Transradial Access for Coronary Catheterization: A Multicenter, Quasi-Randomized Study
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.
- Being tested
- Conventional Transradial Artery Access, Distal Radial Artery Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Transradial Artery AccessProcedure or surgery
Using Conventional Transradial Artery Access for Cardiac Catheterization
Distal Radial Artery AccessProcedure or surgery
Using Distal Radial Artery access for Cardiac Catheterization
| Study group | Role | What they receive |
|---|---|---|
| Conventional Transradial Access Group | Experimental | Not described Receives: Procedure: Conventional Transradial Artery Access |
| Distal Radial Artery Access Group | Experimental | Not described Receives: Procedure: Distal Radial Artery Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours and 1-6 months post procedure
Secondary outcomes (4)
Access-Site Pain
The patients will be asked to rate their pain on a 1-10 scale.
Measured: 24 hours and 1-6 months post-procedure.
Crossover to Alternative Access Site
In cases where radial access is unsuccessful, crossover to an alternative access site, such as the contralateral radial or femoral artery, will be documented
Measured: At the time of procedure
Access-Site Numbness
Number of participants with numbness at the access site assessed by physical examination.
Measured: 24 hours and 1-6 months post-procedure
Access-Site Bruising
Number of participants with bruising at the access site assessed by physical examination.
Measured: 24 hours and 1-6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Feb 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery Occlusion Following Coronary CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated using an alternating sequence (quasi-randomized, non-concealed allocation), reflecting real-world practice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordanian Research and Artificial Intelligence Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Izraiq, Medical Doctor, Principal investigator, The Specialty HospitalRaed Aqel, Medical Doctor, Principal investigator, Al-Mezan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138170
- Sponsor's protocol ID
- RADIAL-REAL
- Status last verified
- May 2026
- First submitted
- 10 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28636520
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Distal and Conventional Transradial Access for Coronary Catheterization: A Multicenter, Quasi-Randomized Study
- ClinicalTrials.gov ID
- NCT07138170
- Acronym / sponsor ID
- RADIAL-REAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Jordanian Research and Artificial Intelligence GroupUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were allocated using an alternating sequence (quasi-randomized, non-concealed allocation), reflecting real-world practice.
| Arm | Type | Receives |
|---|---|---|
| Conventional Transradial Access Group | Experimental | Procedure: Conventional Transradial Artery Access |
| Distal Radial Artery Access Group | Experimental | Procedure: Distal Radial Artery Access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Transradial Artery AccessUsing Conventional Transradial Artery Access for Cardiac Catheterization | Procedure or surgery | Conventional Transradial Access Group |
| Distal Radial Artery AccessUsing Distal Radial Artery access for Cardiac Catheterization | Procedure or surgery | Distal Radial Artery Access Group |
Primary outcome
Radial artery occlusion (RAO) assessed by duplex ultrasonography
Time frame: 24 hours and 1-6 months post procedure
Radial artery occlusion defined as absence of antegrade flow on duplex ultrasonography, assessed within 24 hours and at 1-6 months after the procedure.
4 secondary outcomes
Access-Site Pain
Time frame: 24 hours and 1-6 months post-procedure.
Crossover to Alternative Access Site
Time frame: At the time of procedure
Access-Site Numbness
Time frame: 24 hours and 1-6 months post-procedure
Access-Site Bruising
Time frame: 24 hours and 1-6 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 28636520Sinha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Izraiq, Medical Doctor principal investigator
The Specialty Hospital
Raed Aqel, Medical Doctor principal investigator
Al-Mezan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Transradial Artery Access and Distal Radial Artery Access in people with Radial Artery Occlusion Following Coronary Catheterization, run by Jordanian Research and Artificial Intelligence Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (RAO) assessed by duplex ultrasonography (time frame: 24 hours and 1-6 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.