Interventional Ventricular Assist System for PCI in CHIP Patients

NCT ID: NCT06373120

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2026-02-13

Brief 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. 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.

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.

Conditions

High-Risk Percutaneous Coronary Intervention (High-risk PCI); Left Ventricular Assist Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microaxial flow pump

The microaxial flow pump (The CorVad percutaneous ventricular assist system) will offer intraoperative hemodynamic support during high-risk PCI procedures.

Group Type: EXPERIMENTAL

Microaxial flow pump

Intervention Type: DEVICE

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-ECMO

The VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures.

Group Type: ACTIVE_COMPARATOR

VA-ECMO

Intervention Type: DEVICE

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.

Interventions

Microaxial flow pump

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.

Intervention Type: DEVICE

VA-ECMO

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18 Years to 90 Years

2. 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

3. The subject is diagnosed with acute or chronic coronary syndrome, and

1. LVEF≤ 35% or

2. LVEF ≤ 40% and NYHA Classification is III or IV

4. Patients who are able to give informed consent and complete the follow-up

1. At least two vessel chronic total occlusions (CTOs) (diameter of occluded artery ≥ 2.5mm)

2. Unprotected left main coronary artery disease, and meeting one or more complex PCI maneuver criteria

3. Three-vessel disease and meeting two or more complex PCI criteria

Complex PCI maneuvers are defined as:

1. Bifurcation require the treatment of both branches (including stents or PTCA)

2. Calcification require Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy

3. Severe tortuosity

4. Target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 points)

Exclusion Criteria

1. Had mechanical circulatory support treatment (such as IABP, ECMO, pVAD) before randomization

2. Acute myocardial infarction or with thrombolytic treatment within 7 days

3. Cardiopulmonary resuscitation within 24 hours

4. 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

5. 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)

6. Abnormal coagulation function (routine blood test indicates platelet count less than 50×109/L, or more than 700×109/L)

7. Active visceral bleeding occurred within 1 month

8. Ischemic or hemorrhagic stroke occurred within 1 month

9. Known contraindication to antiplatelet and anticoagulant medications

10. Known contraindication to medications such as Heparin or contrast.

11. Need for dialysis treatment

12. Active infection

13. Expected life span of less than one year

14. 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)

15. Currently participating in another trial and not yet at its primary endpoint

16. Severe pulmonary arterial hypertension

17. Severe right heart failure or severe tricuspid regurgitation

18. Unforeseen circumstances that the researcher has deemed to be inappropriate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Core Medical Technology CO.,LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Tao, M.D., Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Chao Gao, M.D., Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Locations

Ling Tao

Xi'an, Shannxi, China

Countries

China

Other Identifiers

QX20231057-X-1

Identifier Type: -

Identifier Source: org_study_id