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High-Risk Percutaneous Coronary Intervention (High-risk PCI)REC-CHIPMCSNCT06373120

Interventional Ventricular Assist System for PCI in CHIP Patients

A study testing Microaxial flow pump and VA-ECMO in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI) and Left Ventricular Assist Devices, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Microaxial flow pump and VA-ECMO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteChina
Study dates
4 Mar 2024to 13 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 Years to 90 Years
  • The Heart Team determined that the patients required coronary artery revascularization, but there is a high risk of CABG or the patients refuses CABG. After evaluation by the Heart Team, it was concluded that the patients can benefit from revascularization by undergoing high risk PCI
  • The subject is diagnosed with acute or chronic coronary syndrome, and
  • LVEF≤ 35% or
  • LVEF ≤ 40% and NYHA Classification is III or IV
  • Patients who are able to give informed consent and complete the follow-up
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  • Image inclusion criteria
  • At least two vessel chronic total occlusions (CTOs) (diameter of occluded artery ≥ 2.5mm)
  • Unprotected left main coronary artery disease, and meeting one or more complex PCI maneuver criteria
  • Three-vessel disease and meeting two or more complex PCI criteria
  • Complex PCI maneuvers are defined as:
  • Bifurcation require the treatment of both branches (including stents or PTCA)
  • Calcification require Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy
  • Severe tortuosity
  • Target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 points)

Who cannot join

  • Had mechanical circulatory support treatment (such as IABP, ECMO, pVAD) before randomization
  • Acute myocardial infarction or with thrombolytic treatment within 7 days
  • Cardiopulmonary resuscitation within 24 hours
  • Cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or requiring vasoactive drugs to maintain systolic blood pressure above 90 mmHg) or hemodynamically unstable
  • pVAD and ECMO cannot be inserted or contraindicated (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contraction device, moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency, peripheral stents, tortuosity, dissection and other severe vascular diseases obstructing the insertion of the study device, aortic dissection, aneurysm or severe abnormalities of the ascending aorta and/or aortic arch, red blood cell fragility or blood disorders, hypertrophic obstructive cardiomyopathy)
  • Abnormal coagulation function (routine blood test indicates platelet count less than 50×109/L, or more than 700×109/L)
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  • Active visceral bleeding occurred within 1 month
  • Ischemic or hemorrhagic stroke occurred within 1 month
  • Known contraindication to antiplatelet and anticoagulant medications
  • Known contraindication to medications such as Heparin or contrast.
  • Need for dialysis treatment
  • Active infection
  • Expected life span of less than one year
  • Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
  • Currently participating in another trial and not yet at its primary endpoint
  • Severe pulmonary arterial hypertension
  • Severe right heart failure or severe tricuspid regurgitation
  • Unforeseen circumstances that the researcher has deemed to be inappropriate

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ling Tao

    Xi'an, Shannxi, 710032

Other trials in China

About this study

Official title: Interventional Ventricular Assist System for PCI in Complicated and High-risk Patient: a Prospective, Multicenter, Randomized Trial

In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).

During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.

Read more

There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.

The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI.

Being tested
Microaxial flow pump, VA-ECMO
Keywords
Microaxial flow pump, ECMO, Percutaneous Coronary Intervention, left ventricular assist devices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microaxial flow pumpDevice

    The microaxial flow pump (The CorVad percutaneous ventricular assist system device) is a microaxial rotary blood pump that expels blood from the left ventricle into the ascending aorta, thus unloading the left ventricle. The CorVad system device can be introduced through a femoral percutaneous approach (14Fr) and can deliver an output of up to 4-6 L/min.

  • VA-ECMODevice

    Veno-arterial extracorporeal Membrane Oxygenation (VA-ECMO) is a device originally created to replace heart and lung function. Venous deoxygenated blood is mechanically suctioned from a large central vein through a venous cannula by a centrifugal pump. It is then oxygenated, warmed, and restored into systemic circulation through an arterial cannula.

Study groups in NCT06373120
Study groupRoleWhat they receive
Microaxial flow pumpExperimentalThe microaxial flow pump (The CorVad percutaneous ventricular assist system) will offer intraoperative hemodynamic support during high-risk PCI procedures.
Receives: Device: Microaxial flow pump
VA-ECMOActive comparatorThe VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures.
Receives: Device: VA-ECMO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse event

    Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation

    Measured: 1 month

Secondary outcomes (17)

  1. All-cause death

    Measured: 1, 3, 12, 24, 36, and 60 months

  2. Stroke

    Measured: 1, 3, 12, 24, 36, and 60 months

  3. Myocardial infarction

    Measured: 1, 3, 12, 24, 36, and 60 months

  4. Revascularization

    Measured: 1, 3, 12, 24, 36, and 60 months

  5. Cardiovascular hospitalization

    Rehospitalization due to cardiovascular reasons

    Measured: 1, 3, 12, 24, 36, and 60 months

  6. MCS-ARC defined type 3, 4, 5 bleeding

    Bleeding is defined by the "Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium" (MRC-ARC)

    Measured: 1 month

  7. Acute kidney injury

    Measured: 1 month

  8. Serious device-related adverse events

    Including but not limited to cardiac structural impairment, severe limb ischemia (pale, pulseless, and necrotic), infection, aortic and aortic valve impairment, hemolysis, peri-procedural complications that cause death, permanent/severe disability to the subject, or significantly prolonged hospital stay or need for surgical intervention

    Measured: 1 month

  9. Cardiopulmonary resuscitation

    Measured: 1 month

  10. Hospitalization time

    Measured: 1 month

  11. Intensive care unit (ICU/CCU) stay time

    Measured: 1 month

  12. ECMO/Corvad utilization time

    Measured: 1 month

  13. Hemodynamic disorder

    Hemodynamic disorder is defined as average arterial pressure (MAP) below 60 mmHg for more than 10 minutes with the requirement of additional vasoactive medications

    Measured: 1 month

  14. Transfusion rate

    Transfusion rate is defined as patients who had transfusion / all enrolled patients.

    Measured: 1 month

  15. Units of transfusion

    Measured: 1 month

  16. Major adverse event

    Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation

    Measured: 3, 12, 24, 36, and 60 months

  17. Major Adverse Cardiovascular and Cerebrovascular Events

    Major Adverse Cardiovascular and Cerebrovascular Events is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization

    Measured: 1, 3, 12, 24, 36, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start4 Mar 2024
  3. Primary completion13 Feb 2025
  4. Study completion13 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of CorVad compared to VA-ECMO in complicated and high-risk patient with indications for PCI
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373120
Sponsor's protocol ID
QX20231057-X-1
Acronym
REC-CHIPMCS
Status last verified
Jan 2026
First submitted
11 Mar 2024
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Microaxial flow pump and VA-ECMO in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI) and Left Ventricular Assist Devices, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse event (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06373120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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