Radial Artery OcclusionPhase 4RIVA-RAONCT06812455
Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization
A Phase 4 study testing Rivaroxaban in people with Radial Artery Occlusion, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The purpose of the RIVA-RAO study is to determine whether the use of Rivaroxaban is an effective treatment of radial artery occlusion (RAO) after cardiac catheterization (both angiography and PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2025to 1 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure
- Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)
Who cannot join
- Age < 18 years
- Unable to provide informed written consent
- Any contraindication to receive Rivaroxaban
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital
Thessaloniki, 54636
Areti Pagiantza, MD, 2313303736 ext. +30, apayantza@gmail.com
Areti Pagiantza, MD
About this study
Official title: Effect of RIVAroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
The purpose of the RIVA-RAO study is to determine whether the use of Rivaroxaban is an effective treatment of radial artery occlusion (RAO) after cardiac catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving Rivaroxaban and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure.
Study objectives:
Read more
Primary objective:
To evaluate the effect of treatment with Rivaroxaban, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 4 weeks after the procedure, compared with no-anticoagulation treatment.
Secondary objectives:
To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 4 weeks after the procedure between the two groups.
Read the detailed description
The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safer hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound).
Although perceived as usually asymptomatic, RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting.
Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today the only randomized studies reagrding RAO treatment have used either low-molecular-weight-heparin (LMWH) or apixaban.
This is a prospective, randomized study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.
RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients.
Patients diagnosed with RAO will be randomized 1:1 into two groups:
Treatment group, that will receive Rivaroxaban for 4 weeks. Control group, that will not receive any anticoagulation.
All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.
- Conditions
- Radial Artery Occlusion
- Being tested
- Rivaroxaban
- Keywords
- radial artery occlusion, complications, transradial, coronary catheterization, treatment
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Patients with RAO that will receive p.o. tabs Rivaroxaban 20 mg q.d.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients with RAO that will receive Rivaroxaban Receives: Drug: Rivaroxaban |
| Control | No intervention | Patients with RAO that will not receive any anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery patency
Radial artery patency at 4 weeks after the procedure, evaluated with radial artery ultrasound.
Measured: 4 weeks
Secondary outcomes (1)
Bleeding events
To compare bleeding events (based on the BARC bleeding definition) at 4 weeks after the procedure.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Radial Artery OcclusionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthaios Didagelos, AHEPA University Hospital
- Investigators
- Antonios Ziakas, Professor, Study chair, AHEPA University Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812455
- Sponsor's protocol ID
- 107/2025
- Acronym
- RIVA-RAO
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amirpour A, Zavar R, Seifipour A, Sadeghi M, Shirvani E, Kermani-Alghoraishi M, Sanei H, Hashemi Jazi SM, Pourmoghaddas A, Khosravi Farsani A, Zarepour E, Safaei A, Hassannejad R. Apixaban, a Novel Oral Anticoagulant, Use to Resolute Arterial Patency in Radial Artery Occlusion Due to Cardiac Catheterization; A Pilot Randomized Clinical Trial. ARYA Atheroscler. 2023 Nov-Dec;19(6):18-26. doi: 10.48305/arya.2023.41915.2909.
PubMed 38883851Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
PubMed 31753298Tsigkas G, Papanikolaou A, Apostolos A, Kramvis A, Timpilis F, Latta A, Papafaklis MI, Aminian A, Davlouros P. Preventing and Managing Radial Artery Occlusion following Transradial Procedures: Strategies and Considerations. J Cardiovasc Dev Dis. 2023 Jun 30;10(7):283. doi: 10.3390/jcdd10070283.
PubMed 37504539Didagelos M, Pagiantza A, Zegkos T, Papanastasiou C, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Sianos G, Karvounis H, Ziakas A. Low-molecular-weight heparin in radial artery occlusion treatment: the LOW-RAO randomized study. Future Cardiol. 2022 Feb;18(2):91-100. doi: 10.2217/fca-2021-0067. Epub 2021 Aug 16.
PubMed 34397270Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.
PubMed 35981848
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RIVAroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
- ClinicalTrials.gov ID
- NCT06812455
- Acronym / sponsor ID
- RIVA-RAO / 107/2025
- Conditions
- Radial Artery Occlusion
- Keywords
- radial artery occlusion, complications, transradial, coronary catheterization, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 6 Feb 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.
The purpose of the RIVA-RAO study is to determine whether the use of Rivaroxaban is an effective treatment of radial artery occlusion (RAO) after cardiac catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving Rivaroxaban and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure.
Study objectives:
Primary objective:
To evaluate the effect of treatment with Rivaroxaban, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 4 weeks after the procedure, compared with no-anticoagulation treatment.
Secondary objectives:
To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 4 weeks after the procedure between the two groups.
Detailed description
The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safer hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound).
Although perceived as usually asymptomatic, RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting.
Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today the only randomized studies reagrding RAO treatment have used either low-molecular-weight-heparin (LMWH) or apixaban.
This is a prospective, randomized study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.
RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients.
Patients diagnosed with RAO will be randomized 1:1 into two groups:
Treatment group, that will receive Rivaroxaban for 4 weeks. Control group, that will not receive any anticoagulation.
All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: RivaroxabanPatients with RAO that will receive Rivaroxaban |
| Control | No intervention | –Patients with RAO that will not receive any anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure
- Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)
Key exclusion criteria (3 listed)
- Age < 18 years
- Unable to provide informed written consent
- Any contraindication to receive Rivaroxaban
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 |
|---|---|---|
| RivaroxabanPatients with RAO that will receive p.o. tabs Rivaroxaban 20 mg q.d. | Drug | Intervention |
Primary outcome
Radial artery patency
Time frame: 4 weeks
Radial artery patency at 4 weeks after the procedure, evaluated with radial artery ultrasound.
1 secondary outcome
Bleeding events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 38883851Amirpour A, Zavar R, Seifipour A, Sadeghi M, Shirvani E, Kermani-Alghoraishi M, Sanei H, Hashemi Jazi SM, Pourmoghaddas A, Khosravi Farsani A, Zarepour E, Safaei A, Hassannejad R. Apixaban, a Novel Oral Anticoagulant, Use to Resolute Arterial Patency in Radial Artery Occlusion Due to Cardiac Catheterization; A Pilot Randomized Clinical Trial. ARYA Atheroscler. 2023 Nov-Dec;19(6):18-26. doi: 10.48305/arya.2023.41915.2909.
- Background: PubMed 31753298Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
- Background: PubMed 37504539Tsigkas G, Papanikolaou A, Apostolos A, Kramvis A, Timpilis F, Latta A, Papafaklis MI, Aminian A, Davlouros P. Preventing and Managing Radial Artery Occlusion following Transradial Procedures: Strategies and Considerations. J Cardiovasc Dev Dis. 2023 Jun 30;10(7):283. doi: 10.3390/jcdd10070283.
- Background: PubMed 34397270Didagelos M, Pagiantza A, Zegkos T, Papanastasiou C, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Sianos G, Karvounis H, Ziakas A. Low-molecular-weight heparin in radial artery occlusion treatment: the LOW-RAO randomized study. Future Cardiol. 2022 Feb;18(2):91-100. doi: 10.2217/fca-2021-0067. Epub 2021 Aug 16.
- Background: PubMed 35981848Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.
- 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.
Antonios Ziakas, Professor study chair
AHEPA University Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban in people with Radial Artery Occlusion, run by AHEPA University Hospital at 1 site in Greece.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthaios Didagelos, MD, MSc, PhD (2310994830 ext. +30, manthosdid@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery patency (time frame: 4 weeks). 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 NCT06812455, which also lists 5 linked publications.
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 Feb 2025.