Interventional Ventricular Assist System for PCI in CHIP Patients

Not Applicable

Active, not recruiting

• Conditions: Left Ventricular Assist Devices; High-Risk Percutaneous Coronary Intervention (High-risk PCI)
• Interventions: Device: CorVad; Device: VA-ECMO

• Registration Number: NCT06373120
• Lead Sponsor: Shenzhen Core Medical Technology CO.,LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Primary Completion: 2025-02-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Completion: 2026-02-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 262

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

Image inclusion criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CorVad	CorVad	The CorVad percutaneous ventricular assist system will offer intraoperative hemodynamic support during high-risk PCI procedures.
VA-ECMO	VA-ECMO	The VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures.

Primary Outcome Measures

Name	Time	Method
Major adverse event	1 month	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

Secondary Outcome Measures

Name	Time	Method
All-cause death	1, 3, 12, 24, 36, and 60 months
Stroke	1, 3, 12, 24, 36, and 60 months
Revascularization	1, 3, 12, 24, 36, and 60 months
MCS-ARC defined type 3, 4, 5 bleeding	1 month	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)
Myocardial infarction	1, 3, 12, 24, 36, and 60 months
Cardiovascular hospitalization	1, 3, 12, 24, 36, and 60 months	Rehospitalization due to cardiovascular reasons
Acute kidney injury	1 month
Serious device-related adverse events	1 month	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
Cardiopulmonary resuscitation	1 month
Hospitalization time	1 month
Intensive care unit (ICU/CCU) stay time	1 month
ECMO/Corvad utilization time	1 month
Hemodynamic disorder	1 month	Hemodynamic disorder is defined as average arterial pressure (MAP) below 60 mmHg for more than 10 minutes with the requirement of additional vasoactive medications
Transfusion rate	1 month	Transfusion rate is defined as patients who had transfusion / all enrolled patients.
Units of transfusion	1 month
Major adverse event	3, 12, 24, 36, and 60 months	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

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China