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New patch and ultrasound aim to make wrist heart procedures safer and faster

NCT ID NCT06835829

Knowledge-focused Sponsor: Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 5 times

Summary

This study tests two improvements for heart catheterization done through a small artery in the wrist. First, it checks if a special patch can stop bleeding faster. Second, it sees if using ultrasound to guide the needle makes the procedure more successful. About 480 adults needing heart tests or treatment will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
potassium ferrate hemostatic patch
What this could lead to
If successful, this could make wrist-based heart catheterization faster and more reliable, reducing complications and improving patient comfort.
What could go wrong
This is a mid-sized pragmatic trial, not a large Phase 3 study. The patch and ultrasound technique may not show meaningful improvement over standard care, and results may not apply to all hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary catheterization

Contacts and locations

Locations

  • CHU Charleroi-Chimay, Marie Curie Hospital

    Charleroi, 6042, Belgium

  • CHU Helora, Jolimont Hospital

    La Louvière, 7100, Belgium

  • Groupe Vivalia, Clinique Saint-Joseph

    Arlon, 6700, Belgium

  • Mater Salutis Hospital

    Legnago, VR, 37045, Italy

  • Sandro Pertini Hospital

    Roma, RM, 00157, Italy

  • Sant'Eugenio Hospital

    Roma, RM, 00144, Italy

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