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Heart pump may protect patients during risky stent procedures

NCT ID NCT05003817

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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: 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.