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Can a heart pump make risky stent placements safer?

NCT ID NCT07380217

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using a temporary mechanical heart pump during a high-risk heart procedure (PCI) can improve safety and outcomes. About 98 adults with weak hearts and complex blockages will be randomly assigned to receive the pump or standard care. The goal is to see if the pump reduces complications like death, shock, or organ failure.

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 98 people

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

Started

Jan 2024

Expected to finish

Mar 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 AND * Multidisciplinary heart team consensus for high risk PCI +/- MCS AND * Hemodynamically stable (SCAI A-B) AND * LVEF \<30% OR LVEF \<35% with moderate MR OR LVEF \<40% with severe MR AND * Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native). Exclusion Criteria: * Contraindications for Pulsecath IVAC2L: 1. severe aortic regurgitation 2. known presence of an LV thrombus (contrast echo/MRI) 3. Mechanical aorta valve prosthesis 4. severe aortic valve stenosis 5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device * Cardiogenic shock defined as either SCAI CSWG stage C-E * Patient is intubated and mechanically ventilated * Stroke \<3 months * Major bleeding event \<3 months * History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy * Pregnancy, or suspected thereof. * BMI \> 35 * Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures. * Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    8 sites. 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

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, Netherlands

  • Haaglanden Medical Center

    RECRUITING

    The Hague, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, Netherlands

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, Netherlands

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Netherlands

  • Zuyderland

    RECRUITING

    Geleen, Netherlands

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