Heart pump may protect patients during risky stent procedures
NCT ID NCT05003817
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests whether a temporary heart pump can help high-risk patients during coronary stenting. The pump supports the heart's main chamber during the procedure, aiming to prevent heart failure or death. About 300 patients with severe coronary disease and weak heart muscle will be randomly assigned to receive the pump or standard care. The trial will compare rates of death, stroke, heart attack, and hospital stays.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- percutaneous left ventricular unloading device (a temporary heart pump)
- What this could lead to
- If it works, this could provide a safer way to perform stenting in high-risk patients, reducing serious complications like heart failure or death.
- What could go wrong
- This is a Phase 3 trial, but the device itself carries risks like bleeding or leg artery damage, and it is expensive. The benefit over standard care is not yet proven.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
300 people
The number who actually took part.
- Started
-
Aug 2021
- Expected to finish
-
Dec 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.
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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: 1. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8\* 2. Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)# 3. Complex PCI defined by the presence of at least one of the following criteria: * Unprotected left main intervention in the presence of * an occluded dominant right coronary artery, or * a left dominant circulation, or * disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1) * Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser) * in multiple vessels or * in the left main stem, or * in a final patent conduit, or * where the anatomic SYNTAX score is ≥32 * Target vessel is a chronic total occlusion with planned retrograde approach * In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium. * Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF. Exclusion Criteria: 1. Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device) 2. Contraindication to pLVAD insertion 3. Inability to give informed consent 4. Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes
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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.
Contacts and locations
Locations
-
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
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