ClinicalTrials.gg
Not yet recruitingNCT07678021PIVOTUpdated Jul 1, 2026

Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction

An interventional study of Microaxial pump-supported PCI and Optimal medical therapy (OMT) in Coronary Artery Disease (CAD), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
452
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump) for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction. Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled. The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy. This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.

02

Conditions studied

  • Coronary Artery Disease (CAD)

Keywords

  • Left ventricular assist system
  • complex coronary heart disease
  • left ventricular dysfunction
  • randomized controlled study
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 452 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject is aged ≥18 years;
  2. The subject has been diagnosed with chronic or acute coronary syndrome and has a \<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 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

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 (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 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 , 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. 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
452 participants (estimated)

Study arms

  • Experimental
    Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm

    Participants assigned to the intervention arm will undergo PCI supported by the micro-axial flow pump, in addition to optimal medical therapy (OMT).

    Device: Microaxial pump-supported PCI · Drug: Optimal medical therapy (OMT)

  • Other
    Optimal medical therapy (OMT) alone arm

    Participants in this arms will receive guideline-directed optimal medical therapy (OMT) as determined by the heart failure team at each center.

    Drug: Optimal medical therapy (OMT)

Interventions

  • DeviceMicroaxial pump-supported PCI

    Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients

  • DrugOptimal medical therapy (OMT)

    Guideline-directed OMT will be determined by the heart failure team at each center. OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities. Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat.

06

What researchers measure

Primary outcomes

  1. 1-year MACCE

    a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure

    Time frame: Up to 1 year after enrollment

Secondary outcomes

  1. Perioperative myocardial infarction

    Time frame: Up to 48h after the index PCI procedure

  2. Types 3, 4, and 5 bleeding as defined by MCS-ARC

    Time frame: Up to 1 year after enrollment

  3. Severe hemolysis related to the device

    Time frame: Up to 72 hours after the implantation of the CorVad left ventricular assist system

  4. Stent thrombosis

    Time frame: Up to 1 year after the index PCI procedure

07

Study locations

1 site
  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100037, China
    • Kefei Dou, MD, PhD · Contactdrdoukefei@126.com · +86-1380103291
    • Kefei Dou, MD, PhD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07678021
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 1, 2026

Study contacts

Kefei Dou, MD, PhD
Contact
drdoukefei@126.com
+86-13801032912
Guofeng Gao, MD
Contact
ggf03@163.com
+8613811458815

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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