Interventional Ventricular Assist System for PCI in CHIP Patients (NCT06373120) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Interventional Ventricular Assist System for PCI in CHIP Patients
China262 participantsStarted 2024-03-04
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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