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New heart pump could be safer for High-Risk patients

NCT ID NCT07010965

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

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

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

236 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

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. 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

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, China

  • Fuwai Yunnan Hospital Chinese Academy of Medical Science

    Yunnan, China

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Nanfang Hospital Southern Medical University

    Guangzhou, China

  • Peking University First Hospital Taiyuan Hospital

    Taiyuan, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Hospital of Lanzhou University

    Lanzhou, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, China

  • The Second Xiangya Hospital of Central South University

    Changsha, China

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, China

  • ZhongShan Hospital Fudan University

    Shanghai, China

More trials for these conditions

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