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