[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593045":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":458,"collaborators":25,"id":460,"slug":461,"hasResults":462,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":462,"sex":467,"minAge":468,"maxAge":469,"enrollmentInfo":470,"targetDuration":25,"studyType":473,"phases":474,"briefSummary":476,"conditions":477,"keywords":25,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":488},{"fullName":5,"class":6},"Magenta Medical Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Elevate","EXPERIMENTAL","Subjects receiving the Elevate System",[13],"Device: Elevate",{"label":15,"type":16,"description":17,"interventionNames":18},"Impella","ACTIVE_COMPARATOR","Subjects receiving the Impella System",[19],"Device: Impella",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The Elevate System is a catheter- mounted, self-expanding and retrievable, continuous-flow pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta, thus augmenting cardiac output and maintaining systemic arterial pressure during complex\u002Fhigh-risk coronary interventions. Subjects will receive an Elevate prior to their high-risk percutaneous intervention.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Subjects will receive an Impella prior to their high-risk percutaneous intervention.",[15],[30,52,68,83,99,113,129,144,159,171,183,195,210,225,240,256,272,287,302,317,331,346,357,368,379,395,411,427,443],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"HonorHealth Scottsdale Shea Medical Center","RECRUITING","Scottsdale","Arizona","85260","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-111.89903,33.50921,{"lat":42,"lon":41},[45,50],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Taral Patel, 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MD","716-881-8299","vsiyer@buffalo.edu",{"name":313,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":318,"status":32,"city":319,"state":290,"zip":320,"country":36,"countryCode":37,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"Northwell Health","Manhasset","11030",{"type":39,"coordinates":322},[323,324],-73.69957,40.79788,{"lat":324,"lon":323},[327],{"name":328,"role":47,"phone":329,"phoneExt":25,"email":330},"Perwaiz Meraj, MD","516-600-1480","Pmeraj@Northwell.edu",{"facility":332,"status":32,"city":290,"state":290,"zip":333,"country":36,"countryCode":37,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"NYU Langone\u002FBellevue\u002FLong Island","10023",{"type":39,"coordinates":335},[336,337],-74.00597,40.71427,{"lat":337,"lon":336},[340,344],{"name":341,"role":47,"phone":342,"phoneExt":25,"email":343},"Louai Razzouk, MD","212-263-5656","Louai.Razzouk@nyulangone.org",{"name":345,"role":51,"phone":25,"phoneExt":25,"email":25},"Dimitrios Bliagos, MD",{"facility":347,"status":32,"city":290,"state":290,"zip":348,"country":36,"countryCode":37,"cosmosGeoPoint":349,"geoPoint":351,"contacts":352},"Mount Sinai","10029",{"type":39,"coordinates":350},[336,337],{"lat":337,"lon":336},[353],{"name":354,"role":47,"phone":355,"phoneExt":25,"email":356},"Amit Hooda, MD","212-241-9687","Amit.hooda@mountsinai.org",{"facility":358,"status":32,"city":290,"state":290,"zip":359,"country":36,"countryCode":37,"cosmosGeoPoint":360,"geoPoint":362,"contacts":363},"Columbia University Medical Center\u002FNYPH","10032",{"type":39,"coordinates":361},[336,337],{"lat":337,"lon":336},[364],{"name":365,"role":47,"phone":366,"phoneExt":25,"email":367},"Margaret McEntegart, MD","212-305-7060","mbm2179@cumc.columbia.edu",{"facility":369,"status":32,"city":290,"state":290,"zip":370,"country":36,"countryCode":37,"cosmosGeoPoint":371,"geoPoint":373,"contacts":374},"Weill Cornell Medical Center","10065",{"type":39,"coordinates":372},[336,337],{"lat":337,"lon":336},[375],{"name":376,"role":47,"phone":377,"phoneExt":25,"email":378},"Jaikirshan Khatri, MD","212-746-4617","Jak4033@med.cornell.edu",{"facility":380,"status":32,"city":381,"state":382,"zip":383,"country":36,"countryCode":37,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"Mercy Health","Cincinnati","Ohio","45211",{"type":39,"coordinates":385},[386,387],-84.51439,39.12711,{"lat":387,"lon":386},[390,394],{"name":391,"role":47,"phone":392,"phoneExt":25,"email":393},"Adam Raskin, MD","513-215-9200","ARaskin@mercy.com",{"name":391,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":396,"status":32,"city":397,"state":398,"zip":399,"country":36,"countryCode":37,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"TriStar Centennial Medical Center","Nashville","Tennessee","37203",{"type":39,"coordinates":401},[402,403],-86.78444,36.16589,{"lat":403,"lon":402},[406,410],{"name":407,"role":47,"phone":408,"phoneExt":25,"email":409},"Brian Jefferson, MD","615-981-2414","brian.jefferson@hcahealthcare.com",{"name":407,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":412,"status":32,"city":413,"state":414,"zip":415,"country":36,"countryCode":37,"cosmosGeoPoint":416,"geoPoint":420,"contacts":421},"Inova Schar Heart & Vascular","Falls Church","Virginia","22042",{"type":39,"coordinates":417},[418,419],-77.17109,38.88233,{"lat":419,"lon":418},[422,426],{"name":423,"role":47,"phone":424,"phoneExt":25,"email":425},"Shashank Sinha, MD","703-776-2828","shashank.sinha@inova.org",{"name":423,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":428,"status":32,"city":429,"state":430,"zip":431,"country":36,"countryCode":37,"cosmosGeoPoint":432,"geoPoint":436,"contacts":437},"Swedish Cherry Hill","Seattle","Washington","98122",{"type":39,"coordinates":433},[434,435],-122.33207,47.60621,{"lat":435,"lon":434},[438,442],{"name":439,"role":47,"phone":440,"phoneExt":25,"email":441},"Christopher Brown, MD","206-320-3919","Christopher.Brown@Swedish.org",{"name":439,"role":51,"phone":25,"phoneExt":25,"email":25},{"facility":444,"status":32,"city":445,"state":446,"zip":447,"country":36,"countryCode":37,"cosmosGeoPoint":448,"geoPoint":452,"contacts":453},"Advocate Aurora Health Research Institute- St. Luke's Medical Center","Milwaukee","Wisconsin","53215",{"type":39,"coordinates":449},[450,451],-87.90647,43.0389,{"lat":451,"lon":450},[454],{"name":455,"role":47,"phone":456,"phoneExt":25,"email":457},"Louie Kostopoulos, MD","414-649-3546","Louie.Kostopoulos@aah.org",{"type":459,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100593045","elevate-high-risk-pci-pivotal-study-100593045",false,"NCT07001332","ELEVATE High-Risk PCI Pivotal Study","ELEVATE III","Inclusion Criteria:\n\n1. Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).\n2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.\n3. Participant signed the informed consent.\n\nExclusion Criteria:\n\n1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.\n2. Prior stroke with any permanent, significant (mRS\\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.\n3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and\u002For anticoagulation therapy within 90 days of the index procedure.\n4. Evidence of left ventricular thrombus.\n5. Aortic valve stenosis\u002Fcalcification (valve area ≤ 1.5 cm2).\n6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).\n7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.\n8. Patient on dialysis.\n9. Known or suspected coagulopathy OR abnormal coagulation parameters.\n10. Known allergy, sensitivity or intolerance to nickel.\n11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.\n12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).\n13. Any non-cardiac condition with a life expectancy \\\u003C 12 months.\n14. Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).\n15. Pregnancy or breast-feeding.\n16. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and\u002For to comply with study procedures.\n17. Subject belongs to a vulnerable population.","ALL","18 Years","88 Years",{"count":471,"type":472},290,"ESTIMATED","INTERVENTIONAL",[475],"NA","The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).",[478],"High-Risk Percutaneous Coronary Intervention (High-risk PCI)","2026-04-24",{"date":481,"type":482},"2026-04-28","ACTUAL",{"date":484,"type":482},"2025-07-25",{"date":486,"type":472},"2027-09-16",{"name":5,"class":6},29]