Coronary CatheterizationALPHA&OMEGANCT06835829
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
A study testing Transradial potassium ferrate hemostatic patch, Distal radial potassium ferrate hemostatic patch and Ultrasound-guidance in people with Coronary Catheterization, run by Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS at 6 sites in 2 countries.
Trial summary
Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Catheterization
- What is being tested?
- Transradial potassium ferrate hemostatic patch, Distal radial potassium ferrate hemostatic patch and Ultrasound-guidance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Dec 2025to 7 Jul 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.
- Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
- Patients planned for coronary angiography or PCI.
- Patients able to provide written informed consent.
- Patient is willing to comply with all study protocol required evaluations.
- Palpable radial pulse both at conventional and distal puncture site.
- Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization.
Who cannot join
- Acute ST-segment elevation myocardial infarction.
- Cardiogenic shock.
- Chronic hemodialysis.
- Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
- Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
- Patients unable to provide written informed consent.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Belgium3 sites
Groupe Vivalia, Clinique Saint-Joseph
Arlon, 6700
CHU Charleroi-Chimay, Marie Curie Hospital
Charleroi, 6042
CHU Helora, Jolimont Hospital
La Louvière, 7100
Italy3 sites
Mater Salutis Hospital
Legnago, VR, 37045
Sant'Eugenio Hospital
Roma, RM, 00144
Sandro Pertini Hospital
Roma, RM, 00157
About this study
Official title: Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial
Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever.
However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation.
The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA\&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.
- Conditions
- Coronary Catheterization
- Being tested
- Transradial potassium ferrate hemostatic patch, Distal radial potassium ferrate hemostatic patch, Ultrasound-guidance, Conventional guidance
- Keywords
- Trasnradial access, Distal radial access, Ultrasound guidance, Potassium ferrate, Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial potassium ferrate hemostatic patchDevice
Use of a potassium ferrate hemostatic patch to enhance transradial access hemostasis
Distal radial potassium ferrate hemostatic patchDevice
Use of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis
Ultrasound-guidanceProcedure or surgery
Ultrasound guidance for distal radial access
Conventional guidanceProcedure or surgery
Conventional guidance for distal radial access
| Study group | Role | What they receive |
|---|---|---|
| Distal radial access | Experimental | Not described Receives: Device: Distal radial potassium ferrate hemostatic patch |
| Conventional transradial access | Active comparator | Not described Receives: Device: Transradial potassium ferrate hemostatic patch |
| Distal radial access ultrasound-guided | Experimental | Not described Receives: Procedure: Ultrasound-guidance |
| Distal radial access conventional guidance | Active comparator | Not described Receives: Procedure: Conventional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis duration.
Time from complete removal of the introducer sheath and initiation of hemostatic compression to definitive complete deflation of the hemostatic device (device fully deflated without any subsequent requirement for reinflation)
Measured: From the time procedure ends until the time hemostasis ends, assessed up to 48 hours.
Access success
Insertion of the introducer sheath into the first distal radial artery attempted, using the randomized puncture strategy
Measured: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed
Secondary outcomes (18)
Vascular access site-related hematoma
Hematoma at the access site through which the procedure was completed, graded by the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) modified classification; reported as grade II or higher and as any hematoma
Measured: From the time hemostasis ends until the time patient is discharged from hospital, assessed up to 30 days.
Vascular access site-related bleeding
Bleeding at the access site through which the procedure was completed, classified by Bleeding Academic Research Consortium (BARC) criteria; reported as type 2 or higher
Measured: From the time procedure ends until the time patient is discharged from hospital, assessed up to 30 days.
Vascular access site-related complication
Composite of modified EASY hematoma grade II or higher, BARC type 2 or higher bleeding, arteriovenous fistula, pseudoaneurysm, or need for vascular intervention at the access site
Measured: From the time procedure ends until the time patient is discharged from hospital, assessed up to 30 days.
Forearm radial artery occlusion
Absence of flow in the forearm radial artery on vascular ultrasound, assessed by an investigator independent of the procedural team
Measured: From at least 6 hours after the procedure (ideally 8 to 24 hours) until the time patient is discharge from hospital, assessed up to 30 days.
Distal radial artery occlusion
Absence of flow at the distal radial puncture site on vascular ultrasound, in patients with distal radial access
Measured: From at least 6 hours after the procedure (ideally 8 to 24 hours) until the time patient is discharge from hospital, assessed up to 30 days.
Effectiveness of patent hemostasis
Reverse Barbeau waveform type A or B during compression, in patients with conventional transradial access
Measured: From the time hemostasis starts until the time hemostasis is optimized, assessed up to 5 minutes.
Number of deflation attempts required to achieve hemostasis
Measured: From the time hemostasis starts until the time hemostasis ends, assessed up to 48 hours.
Hemostasis at the first scheduled deflation attempt
Hemostasis effective at the first scheduled deflation attempt without reinflation during the 30-minute observation window
Measured: From the end of hemostasis to the next 30 minute
Total air volume used for hemostasis compression
Measured: From the time hemostasis starts until the time hemostasis is optimized, assessed up to 5 minutes.
Access time
Time from contact of the anesthesia needle with the skin to proper placement of the introducer sheath, in patients with access success at the first attempted site
Measured: During the index procedure
Puncture attempts
Number of skin punctures with the needle at the first access site; redirection without withdrawal from the skin is not a new attempt
Measured: During the index procedure
Puncture success
Introduction of a guidewire through the punctured distal radial artery at the first attempted site
Measured: During the index procedure
Puncture time
Time from needle contact with the skin to passage of the guidewire through the needle into the artery, in patients with puncture success at the first attempted site
Measured: During the index procedure
First-pass success
Introducer sheath placement after a single puncture attempt
Measured: During the index procedure
Radial artery spasm
Angiographically identified radial artery spasm
Measured: During the index procedure
Puncture strategy switch
Switch from the randomized to the non-randomized puncture strategy (from US-guided to conventional and vice versa)
Measured: During the index procedure
Access site cross-over
Puncture of an access site other than the randomized one, reported as within-randomization (contralateral, same access) or between-randomization (other access)
Measured: During the index procedure
Vascular access site-related pain
Pain felt from access site puncture until sheath removal, on a visual analogue scale from 0 to 10
Measured: Immediately after removal of the introducer sheath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start31 Dec 2025
- Primary completion6 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open-label, randomized, controlled trial that integrates two independent nonfactorial randomized comparisons. In the first comparison, 480 patients will be randomized in 1:1 ratio to either to conventional transradial access or distal radial access using the potassium ferrate patch for hemostasis enhancement. In the second comparison, the 240 patients assigned to distal radial access will be randomized 1:1 to either conventional artery puncture or ultrasound-guided puncture.
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Sgueglia, S.Eugenio Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835829
- Sponsor's protocol ID
- 2023-00123
- Other IDs
- 2023
- Acronym
- ALPHA&OMEGA
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06835829
- Acronym / sponsor ID
- ALPHA&OMEGA / 2023-00123
- Conditions
- Coronary Catheterization
- Keywords
- Trasnradial access, Distal radial access, Ultrasound guidance, Potassium ferrate, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUSUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 19 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.
Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever.
However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation.
The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA\&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective open-label, randomized, controlled trial that integrates two independent nonfactorial randomized comparisons. In the first comparison, 480 patients will be randomized in 1:1 ratio to either to conventional transradial access or distal radial access using the potassium ferrate patch for hemostasis enhancement. In the second comparison, the 240 patients assigned to distal radial access will be randomized 1:1 to either conventional artery puncture or ultrasound-guided puncture.
| Arm | Type | Receives |
|---|---|---|
| Distal radial access | Experimental | Device: Distal radial potassium ferrate hemostatic patch |
| Conventional transradial access | Active comparator | Device: Transradial potassium ferrate hemostatic patch |
| Distal radial access ultrasound-guided | Experimental | Procedure: Ultrasound-guidance |
| Distal radial access conventional guidance | Active comparator | Procedure: Conventional guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
- Patients planned for coronary angiography or PCI.
- Patients able to provide written informed consent.
- Patient is willing to comply with all study protocol required evaluations.
Key exclusion criteria (6 listed)
- Acute ST-segment elevation myocardial infarction.
- Cardiogenic shock.
- Chronic hemodialysis.
- Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
- Medical conditions that may cause non-compliance with the study protocol and/or may confound the 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 |
|---|---|---|
| Transradial potassium ferrate hemostatic patchUse of a potassium ferrate hemostatic patch to enhance transradial access hemostasis | Device | Conventional transradial access |
| Distal radial potassium ferrate hemostatic patchUse of a potassium ferrate hemostatic patch to enhance distal radial access hemostasis | Device | Distal radial access |
| Ultrasound-guidanceUltrasound guidance for distal radial access | Procedure or surgery | Distal radial access ultrasound-guided |
| Conventional guidanceConventional guidance for distal radial access | Procedure or surgery | Distal radial access conventional guidance |
Primary outcome
Hemostasis duration.
Time frame: From the time procedure ends until the time hemostasis ends, assessed up to 48 hours.
Time from complete removal of the introducer sheath and initiation of hemostatic compression to definitive complete deflation of the hemostatic device (device fully deflated without any subsequent requirement for reinflation)
Access success
Time frame: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed
Insertion of the introducer sheath into the first distal radial artery attempted, using the randomized puncture strategy
18 secondary outcomes
Vascular access site-related hematoma
Time frame: From the time hemostasis ends until the time patient is discharged from hospital, assessed up to 30 days.
Vascular access site-related bleeding
Time frame: From the time procedure ends until the time patient is discharged from hospital, assessed up to 30 days.
Vascular access site-related complication
Time frame: From the time procedure ends until the time patient is discharged from hospital, assessed up to 30 days.
Forearm radial artery occlusion
Time frame: From at least 6 hours after the procedure (ideally 8 to 24 hours) until the time patient is discharge from hospital, assessed up to 30 days.
Distal radial artery occlusion
Time frame: From at least 6 hours after the procedure (ideally 8 to 24 hours) until the time patient is discharge from hospital, assessed up to 30 days.
Effectiveness of patent hemostasis
Time frame: From the time hemostasis starts until the time hemostasis is optimized, assessed up to 5 minutes.
Number of deflation attempts required to achieve hemostasis
Time frame: From the time hemostasis starts until the time hemostasis ends, assessed up to 48 hours.
Hemostasis at the first scheduled deflation attempt
Time frame: From the end of hemostasis to the next 30 minute
Total air volume used for hemostasis compression
Time frame: From the time hemostasis starts until the time hemostasis is optimized, assessed up to 5 minutes.
Access time
Time frame: During the index procedure
Puncture attempts
Time frame: During the index procedure
Puncture success
Time frame: During the index procedure
Puncture time
Time frame: During the index procedure
First-pass success
Time frame: During the index procedure
Radial artery spasm
Time frame: During the index procedure
Puncture strategy switch
Time frame: During the index procedure
Access site cross-over
Time frame: During the index procedure
Vascular access site-related pain
Time frame: Immediately after removal of the introducer sheath
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 2 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transradial potassium ferrate hemostatic patch, Distal radial potassium ferrate hemostatic patch and Ultrasound-guidance in people with Coronary Catheterization, run by Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS at 6 sites in 2 countries.
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 7 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Italy. 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?
Hemostasis duration. (time frame: From the time procedure ends until the time hemostasis ends, assessed up to 48 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.