New heart pump could be safer for High-Risk patients
NCT ID NCT07010965
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new, smaller heart pump called NyokAssist to a standard balloon pump in people having high-risk heart procedures to open blocked arteries. The goal is to see if the new pump reduces serious heart and brain complications. About 236 adults will take part in this randomized trial.
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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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236 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
Show the full entry requirements Hide 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. Age eligible (18 ≤ Age ≤ 80) 2. Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft . 3. Patient presence at least one of the following a or b: 1. Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery . 2. Intervention on patient presenting with three-vessel\* disease. * Three-vessel disease was defined as the presence at least one sign ficant stenosis ≥ 50% in the left anterior descending artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, and right coronary artery (RCA) and/or side branch. In the case of left coronary artery dominance, a lesion ≥ 50% in the proximal LAD and the LCX qualified as three-vessel disease. 4. Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support . 5. Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process. Exclusion Criteria: 1. Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction. 2. Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR. 3. Subject is in cardiogenic shock defined as: * CI \< 2.2 L/min/m2 and PCWP \> 15 mmH * Hypotension (systolic BP \< 90 mmHg for \>30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR \[a urine output of \< 30 mL/hour AND a HR \> 60 BPM\]) 4. Mural thrombus in the left ventricle. 5. The presence of aortic valve replacement or mechanical circulatory support device. 6. Subject has mechanical complications of myocardial infarction. 7. Documented presence of severe aortic stenosis. 8. Documented presence of moderate to severe mitral stenosis. 9. Documented presence of severe aortic insufficiency. 10. Severe peripheral arterial obstructive disease that would preclude device placement. 11. Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications. 12. Subject with renal failure (creatinine ≥265μmol/L) 13. Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN ) 14. Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L) 15. History of recent (within 1 month) stroke or TIA . 16. Severe right ventricular dysfunction,such as severe pulmonary hypertension. 17. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media. 18. Subject with documented heparin induced thrombocytopenia. 19. Subject has pregnant or lactating. 20. Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month. 21. Investigators consider unsuitable to participate in the trial.
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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
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Beijing Anzhen Hospital Capital Medical University
Beijing, China
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Fuwai Yunnan Hospital Chinese Academy of Medical Science
Yunnan, China
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Guangdong Provincial People's Hospital
Guangzhou, China
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Nanfang Hospital Southern Medical University
Guangzhou, China
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Peking University First Hospital Taiyuan Hospital
Taiyuan, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
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The First Hospital of Lanzhou University
Lanzhou, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
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The Second Affiliated Hospital of Harbin Medical University
Harbin, China
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The Second Xiangya Hospital of Central South University
Changsha, China
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Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China
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ZhongShan Hospital Fudan University
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can AI read heart scans to predict the next heart attack?
- Can a new drug cool the hidden inflammation that fuels heart disease?
- New CT scanner aims to cut unnecessary heart procedures
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- A soft patch that watches your heart beat in real time