protocolSection identificationModule nctId: NCT06357026, orgStudyIdInfo id: Phitys I -2024, briefTitle: Phitys I™ Percutaneous Left Ventricular Assist System Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shanghai NewMed Medical Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Phigine Medical Technology Co., Ltd., descriptionModule briefSummary: The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous Ventricular Assist System（Phigine Medical）, interventions name: intra-aortic balloon pump (IABP), outcomesModule primaryOutcomes measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE), secondaryOutcomes measure: Incidence of death, secondaryOutcomes measure: Incidence of myocardial infarction, secondaryOutcomes measure: Incidence of stroke, secondaryOutcomes measure: Incidence of target vessel revascularization, secondaryOutcomes measure: Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia, secondaryOutcomes measure: Incidence of acute kidney injury, secondaryOutcomes measure: Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion, secondaryOutcomes measure: Incidence of increasing in aortic insufficiency by more than one grade, secondaryOutcomes measure: Incidence of severe hypotension, secondaryOutcomes measure: Incidence of failure to achieve angiographic success, secondaryOutcomes measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE), secondaryOutcomes measure: Hemodynamic support success rate during PCI procedure, secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Procedural success rate, secondaryOutcomes measure: Change in LVEF compared to baseline, secondaryOutcomes measure: Improvement in cardiac function, secondaryOutcomes measure: Evaluation of Experimental device performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Hospital of Jilin University, city: Jilin, state: Changchun, country: China, contacts name: Bin Liu, role: CONTACT, geoPoint lat: 43.85083, lon: 126.56028, locations facility: The First Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, country: China, contacts name: Yue Li, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Henan Provincial Chest Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Yiqiang Yuan, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Renmin Hospital of Wuhan University, city: Wuhan, state: Hubei, country: China, contacts name: Hong Jiang, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Second Xiangya Hospital of Central South University, city: Changsha, state: Hunan, country: China, contacts name: Shenghua Zhou, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: General Hospital of Northern Theater Command, city: Shenyang, state: Liaoning, country: China, contacts name: Yaling Han, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, city: Shanghai, state: Shanghai, country: China, contacts name: Li Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, country: China, contacts name: Mao Chen, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False