Can a heart pump make risky stent placements safer?
NCT ID NCT07380217
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Amsterdam University Medical Center
RECRUITINGAmsterdam, Netherlands
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Haaglanden Medical Center
RECRUITINGThe Hague, Netherlands
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Leiden University Medical Center
RECRUITINGLeiden, Netherlands
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Maastricht University Medical Center
RECRUITINGMaastricht, Netherlands
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Radboud University Medical Center
RECRUITINGNijmegen, Netherlands
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University Medical Center Groningen
RECRUITINGGroningen, Netherlands
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University Medical Center Utrecht
RECRUITINGUtrecht, Netherlands
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Zuyderland
RECRUITINGGeleen, Netherlands
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