Heart pump may help High-Risk patients get Life-Saving artery treatment
NCT ID NCT07678021
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether using a temporary heart pump (CorVad) during a procedure to open blocked arteries (PCI) can improve outcomes for people with complex coronary artery disease and a very weak heart (ejection fraction below 35%). Half of the 452 participants will receive the pump-assisted PCI plus standard medications, while the other half will receive medications alone. The main goal is to see if the pump reduces major heart and brain events like death, heart attack, stroke, or heart failure readmission over one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CorVad micro-axial flow pump (device) and optimal medical therapy (drugs)
- What this could lead to
- If successful, this approach could offer a safer way to open blocked arteries in people with severely weakened hearts, potentially reducing heart attacks, strokes, and hospitalizations.
- What could go wrong
- This is a mid-stage trial with 452 participants, so results may not apply to everyone. The pump procedure carries risks like bleeding, hemolysis, or stent complications.
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
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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 452 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 80 years
- 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: 1. The subject is aged ≥18 years; 2. The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction \<35%; 3. After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment; 4. The subject has signed an informed consent form approved by the ethics committee, has good compliance after discharge, and is willing to undergo clinical follow-up. 5. At least two vascular occlusive lesions (with the diameter of the occluded vessel \>2.5mm) or unprotected left main coronary artery disease, and meeting one or more complex procedural criteria, or three-vessel disease, and meeting two or more complex procedural criteria; Exclusion Criteria: 1. Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization; 2. Acute myocardial infarction within 7 days or undergoing thrombolytic therapy; 3. Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension; 4. Patients with cardiogenic shock or hemodynamic instability; 5. Cardiopulmonary resuscitation was performed before randomization; 6. Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction; 7. The mechanical circulatory assist device cannot be implanted or there are contraindications (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contractile device, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, presence of stents in peripheral vascular access, tortuosity, dissection, and other severe vascular lesions that hinder the implantation of the investigational device, aortic aneurysm or severe malformation abnormalities, blood cell fragility or hemolytic blood system diseases, hypertrophic or hypertrophic obstructive cardiomyopathy, etc.); 8. Severe abnormalities in platelets, with a count below 50×10\^9/L or above 600×10\^9/L; 9. Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month; 10. Unable to use antiplatelet or anticoagulant drugs; 11. Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications; 12. Severe renal insufficiency, requiring or expected to require long-term dialysis treatment; 13. Severe active infection, puncture site infection, sepsis, or septicemia; 14. Life expectancy is less than or equal to 1 year; 15. Women who are pregnant or breastfeeding; 16. Severe right heart failure or severe tricuspid regurgitation; 17. Participation in other clinical trials has not yet reached the primary endpoint; 18. Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.
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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
1 site. 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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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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