Radial Artery HemostasisRAPHENCT04857385
Radial Artery Puncture Hemostasis Study
A study testing Radial artery hemostasis in people with Radial Artery Hemostasis, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.
Trial summary
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization. A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radial Artery Hemostasis
- What is being tested?
- Radial artery hemostasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesHungary
- Study dates
- 14 Apr 2021to 1 Jan 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary angiogram planned from a radial artery approach
- Use of 5, 6 or 7 French sheaths
Who cannot join
- Radial artery diameter <1.8 mm as measured via ultrasound
- Established peripheral arterial disease
- Known autoimmune illness
- Hemodynamic instability
- Pregnant or nursing
- Condition following resuscitation
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Semmelweis University Heart and Vascular Center
Budapest, 1122
Department of Cardiology and Cardiac Surgery
Debrecen, Hajdú-Bihar, 4032
University of Szeged, Department of Invasive Cardiology
Szeged, Csongád-Csanád, 6725
About this study
Official title: Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.
A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.
Follow-up of the subject will take place 60 days after the index procedure.
- Conditions
- Radial Artery Hemostasis
- Being tested
- Radial artery hemostasis
- Keywords
- Radial artery puncture, Radial artery occlusion, Radial artery bleeding
- 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.
Radial artery hemostasisDevice
Each of the devices will be assessed for radial artery hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Terumo TR Band | Active comparator | Physical standard of care radial hemostasis device. Receives: Device: Radial artery hemostasis |
| StatSeal | Experimental | Potassium-ferrate based chemical hemostasis device. Receives: Device: Radial artery hemostasis |
| Axiostat | Experimental | Chitosan based biological hemostasis device. Receives: Device: Radial artery hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Frequency of radial artery occlusion after hemostasis
Measured: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery occlusion
Frequency of radial artery occlusion after hemostasis
Measured: 60 days (+/-10 days) post-procedure
Radial artery (pseudo)aneurysm formation
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Measured: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery (pseudo)aneurysm formation
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Measured: 60 days (+/-10 days) post-procedure
Radial artery fistula formation
Frequency of radial artery arteriovenous fistula formation after hemostasis
Measured: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery fistula formation
Frequency of radial artery arteriovenous fistula formation after hemostasis
Measured: 60 days (+/-10 days) post-procedure
Radial artery bleeding
Bleeding from the radial artery puncture, classified via the EASY method
Measured: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery bleeding
Bleeding from the radial artery puncture, classified via the EASY method
Measured: 60 days (+/-10 days) post-procedure
Secondary outcomes (3)
Initial compression time of hemostatsis device
Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis
Measured: Up to 30 minutes post-procedure
Overall compression time
Overall time (in minutes) of device use as a hemostatis tool
Measured: Up to 24 hours post-procedure
Number of compression devices needed
Overall number of compression devices needed for hemostatis
Measured: Up to 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start14 Apr 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radial Artery HemostasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Edes, Semmelweis University Heart and Vascular Center
- Investigators
- István F Édes, MD PhD, Principal investigator, Semmelweis Univeristy Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857385
- Sponsor's protocol ID
- RAPHE-001
- Acronym
- RAPHE
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.
PubMed 35694680Kulyassa PM, Nemeth BT, Ruzsa Z, Szuk T, Ehrenberger R, Balazs B, Kakonyi KM, Becker D, Merkely BP, Edes IF. Simplified radial artery haemostasis: using non-compressive dressings-the Radial Artery Puncture Haemostasis Evaluation trial: results of the RAPHE trial. Clin Res Cardiol. 2026 May 26. doi: 10.1007/s00392-026-02942-2. Online ahead of print.
PubMed 42189195
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods
- ClinicalTrials.gov ID
- NCT04857385
- Acronym / sponsor ID
- RAPHE / RAPHE-001
- Conditions
- Radial Artery Hemostasis
- Keywords
- Radial artery puncture, Radial artery occlusion, Radial artery bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Apr 2021 (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.
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.
A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.
Follow-up of the subject will take place 60 days after the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terumo TR Band | Active comparator | Device: Radial artery hemostasisPhysical standard of care radial hemostasis device. |
| StatSeal | Experimental | Device: Radial artery hemostasisPotassium-ferrate based chemical hemostasis device. |
| Axiostat | Experimental | Device: Radial artery hemostasisChitosan based biological hemostasis device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary angiogram planned from a radial artery approach
- Use of 5, 6 or 7 French sheaths
Key exclusion criteria (6 listed)
- Radial artery diameter <1.8 mm as measured via ultrasound
- Established peripheral arterial disease
- Known autoimmune illness
- Hemodynamic instability
- Pregnant or nursing
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 hemostasisEach of the devices will be assessed for radial artery hemostasis. | Device | Axiostat, StatSeal, Terumo TR Band |
Primary outcome
Radial artery occlusion
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Frequency of radial artery occlusion after hemostasis
Radial artery occlusion
Time frame: 60 days (+/-10 days) post-procedure
Frequency of radial artery occlusion after hemostasis
Radial artery (pseudo)aneurysm formation
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Radial artery (pseudo)aneurysm formation
Time frame: 60 days (+/-10 days) post-procedure
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Radial artery fistula formation
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Frequency of radial artery arteriovenous fistula formation after hemostasis
Radial artery fistula formation
Time frame: 60 days (+/-10 days) post-procedure
Frequency of radial artery arteriovenous fistula formation after hemostasis
Radial artery bleeding
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Bleeding from the radial artery puncture, classified via the EASY method
Radial artery bleeding
Time frame: 60 days (+/-10 days) post-procedure
Bleeding from the radial artery puncture, classified via the EASY method
3 secondary outcomes
Initial compression time of hemostatsis device
Time frame: Up to 30 minutes post-procedure
Overall compression time
Time frame: Up to 24 hours post-procedure
Number of compression devices needed
Time frame: Up to 24 hours 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 17 Apr 2024.
- Background: PubMed 35694680Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.
- Derived from this study: PubMed 42189195Kulyassa PM, Nemeth BT, Ruzsa Z, Szuk T, Ehrenberger R, Balazs B, Kakonyi KM, Becker D, Merkely BP, Edes IF. Simplified radial artery haemostasis: using non-compressive dressings-the Radial Artery Puncture Haemostasis Evaluation trial: results of the RAPHE trial. Clin Res Cardiol. 2026 May 26. doi: 10.1007/s00392-026-02942-2. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Radial Artery Hemostasis
Not yet recruitingObservational study
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
Hemostasis, Distal Radial Artery Access (dTRA)
Not yet recruiting
TR Band Combined With Adrenaline Drops Versus TR Band Alone for Radial Artery Hemostasis After Cardiac Catheterization
Radial Artery Hemostasis
Active, not recruiting
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
Coronary Catheterization
Not yet recruiting
Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI
Coronary Angiogram, Early Discharge Trans Radial Angiography
Not yet recruitingObservational study
Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries
Hemostasis of Arterial Punctures
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.
István F Édes, MD PhD principal investigator
Semmelweis Univeristy Heart and Vascular Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial artery hemostasis in people with Radial Artery Hemostasis, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.
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 6 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. 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 (time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)). The study lists 8 primary outcomes in all. 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 NCT04857385, which also lists 2 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 17 Apr 2024.