protocolSection identificationModule nctId: NCT06373120, orgStudyIdInfo id: QX20231057-X-1, briefTitle: Interventional Ventricular Assist System for PCI in CHIP Patients, acronym: REC-CHIPMCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI), conditions: Left Ventricular Assist Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: CorVad, interventions name: VA-ECMO, outcomesModule primaryOutcomes measure: Major adverse event, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Revascularization, secondaryOutcomes measure: Cardiovascular hospitalization, secondaryOutcomes measure: MCS-ARC defined type 3, 4, 5 bleeding, secondaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: Serious device-related adverse events, secondaryOutcomes measure: Cardiopulmonary resuscitation, secondaryOutcomes measure: Hospitalization time, secondaryOutcomes measure: Intensive care unit (ICU/CCU) stay time, secondaryOutcomes measure: ECMO/Corvad utilization time, secondaryOutcomes measure: Hemodynamic disorder, secondaryOutcomes measure: Transfusion rate, secondaryOutcomes measure: Units of transfusion, otherOutcomes measure: Device-related composite endpoint (DoCE), otherOutcomes measure: Patient-related composite endpoint (PoCE), otherOutcomes measure: Net adverse clinical events, otherOutcomes measure: Cardiac death, otherOutcomes measure: Ischemic stroke, otherOutcomes measure: Hemorrhagic stroke, otherOutcomes measure: Transient ischemic attack, otherOutcomes measure: Target vessel myocardial infarction, otherOutcomes measure: Target lesion revascularization, otherOutcomes measure: Target vessel revascularization, otherOutcomes measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR), otherOutcomes measure: Rehospitalization, otherOutcomes measure: MCS-ARC type 2 bleeding, otherOutcomes measure: Puncture complications, otherOutcomes measure: Aortic valve injury, otherOutcomes measure: Active Infection, otherOutcomes measure: ECMO/Corvad setup time, otherOutcomes measure: Complete revascularization rate, otherOutcomes measure: Change in left ventricular ejection fraction (LVEF) from baseline, otherOutcomes measure: Change in New York Heart Association (NYHA) classification from baseline, otherOutcomes measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline, otherOutcomes measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline, otherOutcomes measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline, otherOutcomes measure: Change in creatinine clearance rate from baseline, otherOutcomes measure: Stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ling Tao, status: RECRUITING, city: Xi'an, state: Shannxi, zip: 710032, country: China, contacts name: Chao Gao, M.D., Ph.D., role: CONTACT, phone: 86-18629551066, email: woshigaochao@gmail.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False