[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rayyan Hemetsberger\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Coronary Artery Disease","Heart Failure With Reduced Ejection Fraction",[30,31,32,33,34,15],"Impella CP","Mechanical Circulatory Support","Protected PCI","High-Risk PCI","Hemodynamic Support","NOT_YET_RECRUITING","2026-05-22",{"date":38,"type":39},"2026-05-27","ACTUAL",{"date":41,"type":21},"2026-07-01",{"date":43,"type":21},"2027-10-01",{"name":45,"class":46},"Rayyan Hemetsberger","OTHER",""]