Coronary Artery DiseaseNCT07060820
Association Between Radial Artery Access Point and Radial Artery Spasm
A study testing Radial Artery Puncture at 0-20 mm and Radial Artery Puncture at >21 mm in people with Coronary Artery Disease and Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Radial Artery Spasm
- What is being tested?
- Radial Artery Puncture at 0-20 mm and Radial Artery Puncture at >21 mm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 15 Jan 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
- Adults aged 18 years and older. Patients scheduled for coronary angiography via transradial access. Patients with a palpable radial artery pulse. Patients with a normal Allen test.
Who cannot join
- Abnormal Allen test results. Absence of palpable radial artery pulse. History of prior transradial coronary angiography with hemodynamic instability. Patients with severe comorbid conditions precluding safe participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
VM Medicalpark Mersin Hospital
Mersin, Mezitli, 33200
About this study
Official title: Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures
This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Patients undergoing coronary angiography via radial access will be randomized into two groups based on the puncture site distance: 0-20 mm and >21 mm from the styloid process. The procedure will be performed by experienced interventional cardiologists using standard techniques and medications. The primary goal is to determine if a specific puncture site reduces the incidence of RAS, which is a common complication during transradial procedures. The study will also record procedural details and monitor for other complications to identify the optimal puncture site for reducing RAS and improving patient comfort.
Read the detailed description
The transradial approach (TRA) is the standard vascular access route for diagnostic coronary angiography and percutaneous coronary interventions, in accordance with contemporary guidelines, due to lower bleeding risk, improved patient comfort, and facilitation of early mobilization compared with femoral access. Despite these advantages, radial artery spasm (RAS) remains a common and clinically relevant complication during transradial procedures, often associated with procedural difficulty, the need for access site crossover, and patient discomfort.
RAS is characterised by sudden, transient contraction of the radial artery during sheath insertion or catheter manipulation, which may result in difficulty in catheter advancement, and, in rare cases, procedural failure or catheter entrapment. Several clinical and procedural factors have been identified as being associated with the development of RAS, including female sex, smaller arterial diameter, use of larger sheaths, inadequate sedation, and limited operator experience. Currently radial access is recommended near the styloid process but there is limited data on the effects of different puncture distances from the styloid process on the development of RAS. We examined the impact of different radial artery puncture distances from the styloid process, on the development of radial artery spasm and access-site-related complications.
- Conditions
- Coronary Artery Disease, Radial Artery Spasm
- Being tested
- Radial Artery Puncture at 0-20 mm, Radial Artery Puncture at >21 mm
- Keywords
- Transradial Access, Radial Artery Spasm, Coronary Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Artery Puncture at 0-20 mmProcedure or surgery
Radial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).
Radial Artery Puncture at >21 mmProcedure or surgery
Radial artery puncture performed at a distance greater than 21 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).
| Study group | Role | What they receive |
|---|---|---|
| 0-20 mm Puncture Distance Group | Experimental | Radial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS). Receives: Procedure: Radial Artery Puncture at 0-20 mm |
| 21 mm Puncture Distance Group | Experimental | Radial artery puncture performed 21-40 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS). Receives: Procedure: Radial Artery Puncture at >21 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Spasm during Transradial Coronary Angiography
İnsidance of Radial Artery Spasm during Transradial Coronary Angiography
Measured: During the procedure
Secondary outcomes (1)
Incidence of access site complications
Number of patients experiencing access site complications including hematoma, bleeding, or occlusion within 5 days after the procedure.
Measured: Within 5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Jul 2025
- Primary completion31 Dec 2025
- Study completion15 Jan 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 Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Medicalpark Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vedat ASLAN, MD, Principal investigator, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060820
- Sponsor's protocol ID
- MMP-KAR-VA-01
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is a single-center observational procedural study with limited resources for external data sharing and monitoring. Data can be shared upon reasonable request to the principal investigator in compliance with local regulations.
Publications
Aslan V, Sural S, Yeral N, Gorgulu S, Brilakis ES. Effect of the Distance Between the Radial Artery Puncture Site and the Styloid Process on Radial Artery Spasm in Transradial Coronary Interventions: A Randomized Study. Catheter Cardiovasc Interv. 2026 Jul 16. doi: 10.1002/ccd.70754. Online ahead of print.
PubMed 42460683
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures
- ClinicalTrials.gov ID
- NCT07060820
- Acronym / sponsor ID
- MMP-KAR-VA-01
- Conditions
- Coronary Artery Disease, Radial Artery Spasm
- Keywords
- Transradial Access, Radial Artery Spasm, Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Mersin Medicalpark HastanesiUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 11 Jul 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.
This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Patients undergoing coronary angiography via radial access will be randomized into two groups based on the puncture site distance: 0-20 mm and >21 mm from the styloid process. The procedure will be performed by experienced interventional cardiologists using standard techniques and medications. The primary goal is to determine if a specific puncture site reduces the incidence of RAS, which is a common complication during transradial procedures. The study will also record procedural details and monitor for other complications to identify the optimal puncture site for reducing RAS and improving patient comfort.
Detailed description
The transradial approach (TRA) is the standard vascular access route for diagnostic coronary angiography and percutaneous coronary interventions, in accordance with contemporary guidelines, due to lower bleeding risk, improved patient comfort, and facilitation of early mobilization compared with femoral access. Despite these advantages, radial artery spasm (RAS) remains a common and clinically relevant complication during transradial procedures, often associated with procedural difficulty, the need for access site crossover, and patient discomfort.
RAS is characterised by sudden, transient contraction of the radial artery during sheath insertion or catheter manipulation, which may result in difficulty in catheter advancement, and, in rare cases, procedural failure or catheter entrapment. Several clinical and procedural factors have been identified as being associated with the development of RAS, including female sex, smaller arterial diameter, use of larger sheaths, inadequate sedation, and limited operator experience. Currently radial access is recommended near the styloid process but there is limited data on the effects of different puncture distances from the styloid process on the development of RAS. We examined the impact of different radial artery puncture distances from the styloid process, on the development of radial artery spasm and access-site-related complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-20 mm Puncture Distance Group | Experimental | Procedure: Radial Artery Puncture at 0-20 mmRadial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS). |
| 21 mm Puncture Distance Group | Experimental | Procedure: Radial Artery Puncture at >21 mmRadial artery puncture performed 21-40 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its effect on the incidence of radial artery spasm (RAS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and older. Patients scheduled for coronary angiography via transradial access. Patients with a palpable radial artery pulse. Patients with a normal Allen test.
Key exclusion criteria (1 listed)
- Abnormal Allen test results. Absence of palpable radial artery pulse. History of prior transradial coronary angiography with hemodynamic instability. Patients with severe comorbid conditions precluding safe participation in the study.
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 |
|---|---|---|
| Radial Artery Puncture at 0-20 mmRadial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS). | Procedure or surgery | 0-20 mm Puncture Distance Group |
| Radial Artery Puncture at >21 mmRadial artery puncture performed at a distance greater than 21 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS). | Procedure or surgery | 21 mm Puncture Distance Group |
Primary outcome
Radial Artery Spasm during Transradial Coronary Angiography
Time frame: During the procedure
İnsidance of Radial Artery Spasm during Transradial Coronary Angiography
1 secondary outcome
Incidence of access site complications
Time frame: Within 5 days 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 21 Jan 2026.
- Derived from this study: PubMed 42460683Aslan V, Sural S, Yeral N, Gorgulu S, Brilakis ES. Effect of the Distance Between the Radial Artery Puncture Site and the Styloid Process on Radial Artery Spasm in Transradial Coronary Interventions: A Randomized Study. Catheter Cardiovasc Interv. 2026 Jul 16. doi: 10.1002/ccd.70754. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is a single-center observational procedural study with limited resources for external data sharing and monitoring. Data can be shared upon reasonable request to the principal investigator in compliance with local regulations.
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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.
Vedat ASLAN, MD principal investigator
Toros University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Artery Puncture at 0-20 mm and Radial Artery Puncture at >21 mm in people with Coronary Artery Disease and Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Jan 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 Turkey (Türkiye). 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 Spasm during Transradial Coronary Angiography (time frame: During the 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 NCT07060820, 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 21 Jan 2026.