Interventional Ventricular Assist System for PCI in CHIP Patients

NCT06373120 | Active Not Recruiting DMC

• 1 other identifier: QX20231057-X-1
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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

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

Keywords

Microaxial flow pump; ECMO; Percutaneous Coronary Intervention; left ventricular assist devices

Outcome Measures

Primary Outcomes (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

  1 month

Secondary Outcomes (17)

• All-cause death

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

• Stroke

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

• Myocardial infarction

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

• Revascularization

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

• Cardiovascular hospitalization

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

Other Outcomes (25)

• Device-related composite endpoint (DoCE)

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

• Patient-related composite endpoint (PoCE)

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

• Net adverse clinical events

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

Study Arms (2)

Microaxial flow pump

EXPERIMENTAL

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

Device: Microaxial flow pump

VA-ECMO

ACTIVE COMPARATOR

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

Device: VA-ECMO

Interventions

Microaxial flow pump 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.

Microaxial flow pump

VA-ECMO 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.

VA-ECMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

Location

Study Officials

• Ling Tao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 18, 2024
• Study Start: March 4, 2024
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

CN (1)