Clinical trial NCT06373120: Interventional Ventricular Assist System for PCI in CHIP Patients
Official title: Interventional Ventricular Assist System for PCI in Complicated and High-risk Patient: a Prospective, Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Left Ventricular Assist Devices
Keywords: Microaxial flow pump
ECMO
Percutaneous Coronary Intervention
left ventricular assist devices
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: Major adverse event
timeFrame: 1 month
Secondary outcomes:
measure: All-cause death
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Stroke
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Myocardial infarction
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Revascularization
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Cardiovascular hospitalization
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: MCS-ARC defined type 3, 4, 5 bleeding
timeFrame: 1 month
measure: Acute kidney injury
timeFrame: 1 month
measure: Serious device-related adverse events
timeFrame: 1 month
measure: Cardiopulmonary resuscitation
timeFrame: 1 month
measure: Hospitalization time
timeFrame: 1 month
measure: Intensive care unit (ICU/CCU) stay time
timeFrame: 1 month
measure: ECMO/Corvad utilization time
timeFrame: 1 month
measure: Hemodynamic disorder
timeFrame: 1 month
measure: Transfusion rate
timeFrame: 1 month
measure: Units of transfusion
timeFrame: 1 month
measure: Major adverse event
timeFrame: 3, 12, 24, 36, and 60 months
Other outcomes:
measure: Device-related composite endpoint (DoCE)
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Patient-related composite endpoint (PoCE)
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Net adverse clinical events
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Cardiac death
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Ischemic stroke
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Hemorrhagic stroke
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Transient ischemic attack
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Target vessel myocardial infarction
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Target lesion revascularization
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Target vessel revascularization
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR)
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: Rehospitalization
timeFrame: 1, 3, 12, 24, 36, and 60 months
measure: MCS-ARC type 2 bleeding
timeFrame: 1 month
measure: Puncture complications
timeFrame: 1 month
measure: Aortic valve injury
timeFrame: 1 month
measure: Active Infection
timeFrame: 1 month
measure: ECMO/Corvad setup time
timeFrame: assessed at index PCI procedure
measure: Complete revascularization rate
timeFrame: 1 month
measure: Change in left ventricular ejection fraction (LVEF) from baseline
timeFrame: 1, 12, 24, 36, and 60 months
measure: Change in New York Heart Association (NYHA) classification from baseline
timeFrame: 1, 12, 24, 36, and 60 months
measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline
timeFrame: 1, 12, 36, and 60 months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline
timeFrame: 1, 12, 36, and 60 months
measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline
timeFrame: 1, 12, 36, and 60 months
measure: Change in creatinine clearance rate from baseline
timeFrame: 1 month
measure: Stent thrombosis
timeFrame: 1, 3, 12, 24, 36, and 60 months
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, M.D., Ph.D.
role: STUDY_CHAIR
References: