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Wrist access showdown: could a new approach reduce artery blockage after heart surgery?

NCT ID NCT05490238

Knowledge-focused Sponsor: IGLESIAS Juan Fernando Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether using a wrist artery access point closer to the hand (distal radial) is safer than the usual wrist access for complex heart procedures like opening blocked arteries. About 708 adults with stable or unstable heart conditions will be randomly assigned to one of two access methods. The main goal is to see if the newer approach lowers the risk of forearm artery blockage.

What this could mean

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

What this could lead to
If successful, this could show that a wrist-based approach lowers the chance of artery blockage after complex heart procedures.
What could go wrong
This is an early-stage comparison study, not a treatment trial. Results may not change practice if the new approach is not clearly safer or feasible.

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 708 people

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

Started

Aug 2023

Expected to finish

Jun 2027

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 PCI of complex coronary lesions, such as CTO, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions in whom the operator anticipates that a 7F guiding catheter is indicated. * Patients able to provide written informed consent. Exclusion Criteria: * Patients with acute ST-segment elevation myocardial infarction. * Patients with cardiogenic shock. * Patients on chronic hemodialysis. * Patients with contraindications to TRA, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides. * Patients with 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 vascular occlusion disorder

As listed by the trial registrant

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

Vascular access site occlusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Agaplesion Bethesda Krankenhaus Bergedorf

    RECRUITING

    Hamburg, Germany

  • Basel University Hospital

    RECRUITING

    Basel, Basel, Switzerland

  • CHU Saint-Pierre

    RECRUITING

    Brussels, Belgium

  • CHU de Charleroi

    RECRUITING

    Charleroi, Belgium

  • Clinique St. Joseph Arlon - Groupe Vivalia

    RECRUITING

    Arlon, Belgium

  • Geneva University Hospitals

    RECRUITING

    Geneva, Canton of Geneva, 1205, Switzerland

  • Humanitas Research Hospital

    RECRUITING

    Milan, Italy

  • Hôpital de La Louvière - Site Jolimont

    RECRUITING

    La Louvière, Belgium

  • Patras University Hospital

    RECRUITING

    Pátrai, Greece

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