[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641083":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Impella CP Auto-mode","EXPERIMENTAL","Patients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in Auto-mode (SmartAssist) throughout the protected high-risk percutaneous coronary intervention. In Auto-mode, pump speed (P-level) is automatically adjusted in real time based on hemodynamic feedback, with maximum flow up to approximately 4.3 L\u002Fmin.",[13],"Device: Impella CP",{"label":15,"type":16,"description":17,"interventionNames":18},"Impella CP P-2 Mode","ACTIVE_COMPARATOR","Patients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in the fixed P-2 setting (approximately 1.3-2.1 L\u002Fmin flow) at the start of the procedure. The unblinded study investigator continuously monitors hemodynamics during the procedure and is empowered to escalate Impella support to a higher P-level (or Auto-mode) without operator confirmation if any predefined hemodynamic instability criterion is met (MAP drop ≥ 25 mmHg, MAP \\\u003C 60 mmHg for \\> 1 minute, flat line, catecholamine need, periprocedural resuscitation, or ventilation).",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Impella CP","The Impella CP is a transvalvular axial-flow micro-pump for temporary mechanical circulatory support, inserted via a 14F sheath into the femoral artery and positioned across the aortic valve. The pump draws blood from the left ventricle and delivers it to the ascending aorta, providing forward flow up to approximately 4.3 L\u002Fmin while reducing left ventricular work and end-diastolic pressure. In this study, the device is used in all participants undergoing protected high-risk PCI, with the operating modality (Auto-mode in the experimental arm vs. fixed P-2 mode in the active comparator arm) determined by 1:1 randomization. The unblinded study investigator may escalate Impella support if predefined hemodynamic instability criteria are met.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Serdar Farhan, MD","Lennox Hill Hospital","STUDY_CHAIR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Rayyan Hemetsberger, MD","CONTACT","0043 1 40400 46140","rayyan.hemetsberger@meduniwien.ac.at",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Kevin Hamzaraj, MD","0043 1 40400 46 140","kevin.hamzaraj@meduniwien.ac.at",[42],{"facility":5,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Vienna","State of Vienna","1090","Austria","AT",{"type":49,"coordinates":50},"Point",[51,52],16.37208,48.20849,{"lat":52,"lon":51},[55],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Rayyan Hemetsberger","Head of Heart Catheterization Laboratory","100641083","strategy-success-in-high-risk-pci-with-impella-cp-evaluation-of-hemodynamic-protection-in-complex-pci-100641083",false,"NCT07588399","STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI","Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention","STRATUS-PCI","Inclusion Criteria:\n\n* signed written informed consent\n* age ≥ 18 years\n* presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h)\n* LV-EF ≤ 40 % and one of the following parameters:\n\nLast remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis\n\nExclusion Criteria:\n\n* no written informed consent\n* pregnancy\n* acute infection\n* recent ST-elevation myocardial infarction (\\\u003C 24 hours) or not normalized CK-MB enzymes","ALL","18 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients with weakened heart muscle. The pump is placed temporarily through an artery in the leg and sits across the aortic valve to help maintain blood flow during the procedure.\n\nFifty patients will be randomly assigned in equal numbers to one of two pump settings: an automatic mode that adjusts flow up to higher levels as needed, or a fixed lower-flow mode (P-2). The doctor performing the heart procedure will not know which setting is being used (double-blind). A separate doctor monitors blood pressure and is allowed to change the pump setting at any time if the patient becomes unstable.\n\nThe main question is whether the automatic mode helps doctors complete the planned heart procedure more successfully and without drops in blood pressure or other complications. Results will help design a larger future trial.",[78,79],"Coronary Artery Disease","Heart Failure With Reduced Ejection Fraction",[22,81,82,83,84,66],"Mechanical Circulatory Support","Protected PCI","High-Risk PCI","Hemodynamic Support","NOT_YET_RECRUITING","2026-05-22",{"date":88,"type":89},"2026-05-27","ACTUAL",{"date":91,"type":72},"2026-07-01",{"date":93,"type":72},"2027-10-01",{"name":58,"class":6},1]