[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06445608":3,"trial-entities:NCT06445608":332,"trial-summary:NCT06445608":335},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":86,"locations":89,"central_contacts":319,"overall_officials":324,"references":330,"see_also_links":331},"NCT06445608","000001057","PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm","PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm","RECRUITING","2025-12","2025-06","2025-06-13","2024-09-03","Kardion Inc","INDUSTRY",true,"This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.",null,[19],"Coronary Artery Disease",[21],"High-risk PCI","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},310,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Percutaneous Mechanical Circulatory Support","Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.",[35,36],"Commercial Control","KARDION Cory P4 System",[38,42],{"measure":39,"description":40,"timeFrame":41},"MACCE","The primary effectiveness endpoint of the clinical investigation is a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) comprised of all-cause death, myocardial infarction, stroke\u002FTIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.","30 days post-procedure",{"measure":43,"description":44,"timeFrame":41},"Device-Related Safety","The primary safety endpoint of the clinical investigation is a composite endpoint of device-related safety events (as adjudicated by the CEC) requiring intervention, including cardiac or vascular complication, limb ischemia, increase in aortic insufficiency, or CPR or ventricular arrhythmia requiring cardioversion.",[46,50,54,58,61,64],{"measure":47,"description":48,"timeFrame":49},"Technical Success","Technical Success defined as the ability of the MCS System to be delivered, operated without device malfunction through the end of procedure, and successful retrieval.","Index procedure",{"measure":51,"description":52,"timeFrame":53},"Procedural Success","Procedural Success defined as Technical Success and the ability of the MCS System to provide hemodynamic support preventing severe hypotension and without the need for escalation of mechanical circulatory support (i.e., replacement of the MCS System with a higher output mechanical circulatory support device). Severe hypotension defined as requiring continuous infusion of inotropic\u002Fpressor medications to restore hemodynamics to mean arterial pressure greater than 60 mmHg.","Index Procedure",{"measure":55,"description":56,"timeFrame":57},"Serious Device-Related Adverse Events","Safety Outcome defined as Serious Device-Related Adverse Events (defined as any Serious Adverse Event adjudicated as related to the device by the Clinical Events Committee (CEC)) through 30 days following the index procedure.","Index procedure through 30-day follow-up",{"measure":59,"description":60,"timeFrame":57},"Individual MACCE components","Individual MACCE components: all-cause death, MI, stroke\u002FTIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.",{"measure":62,"description":63,"timeFrame":57},"Death","Cardiovascular death and non-cardiovascular death.",{"measure":65,"description":66,"timeFrame":57},"Health Outcomes Measure: all-cause death","all-cause death","ALL","18 Years","90 Years",false,{"inclusion":72,"exclusion":84,"raw_text":85},[73,74,75,76,77,78,79,80,81,82,83],"Unprotected left main coronary artery stenosis disease","Last remaining epicardial native coronary artery","Significant three vessel coronary artery disease","Significant two vessel coronary artery disease of complex lesions","Significant single vessel coronary artery disease of complex lesions and non-treated CTO","Target vessel is a CTO with planned retrograde approach","Intended calcium modification (by atherectomy, lithotripsy or laser)","In multiple vessels OR","In the left main OR","In a final patent conduit OR","Where the anatomic SYNTAX score is ≥32 3. Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System 4. Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound 5. The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations 6. The subject has been informed of the nature of the trial, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)",[],"Inclusion Criteria:\n\n1. Subject age ≥ 18 and ≤ 90 years at the time of screening\n2. The subject has an LV ejection fraction of \\\u003C 50% (within 90 days of index procedure) AND is at high-risk due to any of the following:\n\n   * Unprotected left main coronary artery stenosis disease\n   * Last remaining epicardial native coronary artery\n   * Significant three vessel coronary artery disease\n   * Significant two vessel coronary artery disease of complex lesions\n   * Significant single vessel coronary artery disease of complex lesions and non-treated CTO\n   * Target vessel is a CTO with planned retrograde approach\n   * Intended calcium modification (by atherectomy, lithotripsy or laser)\n\n     * In multiple vessels OR\n     * In the left main OR\n     * In a final patent conduit OR\n     * Where the anatomic SYNTAX score is ≥32\n3. Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System\n4. Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound\n5. The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations\n6. The subject has been informed of the nature of the trial, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)\n\nExclusion Criteria:\n\n1. Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure\n2. STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and\u002For of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads\n3. Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \\>1x ULN) without CK-MB or Troponin value down trending\n4. Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation\n5. Subjects with sustained ventricular tachycardia or repetitive\u002F prolonged non-sustained ventricular tachycardia or complex ventricular ectopy\n6. Current left ventricular thrombus\n7. Significant right heart failure (right ventricular fractional area change \\\u003C35% on echocardiography)\n8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \\> 70mmHg\n9. Combined cardiorespiratory failure\n10. Presence of an atrial or ventricular septal defect (including post-infarct VSD)\n11. Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis\n12. Cardiogenic shock (Cardiac index \\\u003C 1.8 L\u002Fmin\u002Fm2)\n13. Use of inotropic or pressor therapy within 72 hours of the planned index procedure. NOTE: Use of inotropic or pressor therapy for the sole purpose of blood pressure support associated with anesthesia for the procedure is acceptable.\n14. Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure\n15. Severe aortic valve insufficiency or stenosis or aortic valve replacement\n16. Clinically-relevant vascular disease that precludes the placement of a MCS device\n17. Cerebrovascular Accident (CVA) within 180 days prior to index procedure\n18. Transient Ischemic Attack (TIA) within 90 days prior to index procedure\n19. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g\u002FL)\n20. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia\n21. Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics\n22. Active infection of the intended access site\n23. Chronic renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) and\u002For patients requiring renal replacement therapy with dialysis\n24. KnownHistory of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to index procedure\n25. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 \\\u003C 1.0 L\u002Fs)\n26. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)\n27. Any non-cardiac condition with life expectancy \\\u003C 1 year\n28. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \\> 24 hours with full neurologic recovery). Procedure-related intubation is acceptable.\n29. Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure\n30. Patients with an organ transplant\n31. Patients with implanted left ventricular assist device\n32. Cardiac tamponade\n33. Left ventricular rupture\n34. Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation\n35. Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle\n36. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and\u002For to comply with trial procedures\n37. Current participation in another investigational drug or device trial\n38. Anticipated need for continued MCS support after conclusion of the PCI procedure",[87,88],"ADULT","OLDER_ADULT",[90,105,117,131,144,157,170,182,195,204,217,231,243,255,268,280,293,306],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"Dignity Health - Chandler Regional Medical Center","Chandler","Arizona","85224","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Ashish Pershad, MD","CONTACT","480-728-9973","ashish.pershad@dignityhealth.org",{"lat":103,"lon":104},33.30616,-111.84125,{"facility":106,"status":8,"city":107,"state":93,"zip":108,"country":95,"contacts":109,"geoPoint":114},"HonorHealth Research and Innovation Institute","Scottsdale","85258",[110],{"name":111,"role":99,"phone":112,"email":113},"Taral Patel, MD","480-323-1046","tpatel@honorhealth.com",{"lat":115,"lon":116},33.50921,-111.89903,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":95,"contacts":122,"geoPoint":128},"Arkansas Cardiology, P.A.","Little Rock","Arkansas","72205",[123],{"name":124,"role":99,"phone":125,"phoneExt":126,"email":127},"Ernesto Ruiz-Rodriguez, MD","501-227-7596","1263","eruizrodz@gmail.com",{"lat":129,"lon":130},34.74648,-92.28959,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":95,"contacts":136,"geoPoint":141},"North Suburban Medical Center","Thornton","Colorado","80229",[137],{"name":138,"role":99,"phone":139,"email":140},"Ehrin Armstrong, MD","415-312-2480","earmstrong@clinre.com",{"lat":142,"lon":143},39.86804,-104.97192,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":95,"contacts":149,"geoPoint":154},"Hartford Hospital","Hartford","Connecticut","06112",[150],{"name":151,"role":99,"phone":152,"email":153},"Craig Thompson, MD","802-369-6250","craig.thompson@hhchealth.org",{"lat":155,"lon":156},41.76371,-72.68509,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":95,"contacts":162,"geoPoint":167},"Ascension St. Vincent's","Jacksonville","Florida","32204",[163],{"name":164,"role":99,"phone":165,"email":166},"Samer Garas, MD","904-308-5763","samergaras@yahoo.com",{"lat":168,"lon":169},30.33218,-81.65565,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":95,"contacts":175,"geoPoint":179},"Emory University","Atlanta","Georgia","30322",[176],{"name":177,"role":99,"phone":178},"William Nicholson, MD","404-712-7665",{"lat":180,"lon":181},33.749,-84.38798,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":95,"contacts":187,"geoPoint":192},"Ascension St. Vincent","Indianapolis","Indiana","46290",[188],{"name":189,"role":99,"phone":190,"email":191},"Michael Kourany, MD","317-338-8042","mjkouran@ascension.org",{"lat":193,"lon":194},39.76838,-86.15804,{"facility":196,"status":197,"city":198,"state":199,"zip":200,"country":95,"geoPoint":201},"Massachusetts General Hospital","WITHDRAWN","Boston","Massachusetts","02114",{"lat":202,"lon":203},42.35843,-71.05977,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":95,"contacts":209,"geoPoint":214},"Minneapolis Heart Institute Foundation","Minneapolis","Minnesota","55407",[210],{"name":211,"role":99,"phone":212,"email":213},"Emmanouil Brilakis, MD","612-863-3895","emmanouil.brilakis@allina.com",{"lat":215,"lon":216},44.97997,-93.26384,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":95,"contacts":222,"geoPoint":228},"Deborah Heart and Lung Center","Browns Mills","New Jersey","08015",[223],{"name":224,"role":99,"phone":225,"phoneExt":226,"email":227},"Muhmammad Raza, MD","604-893-1200","5032","razam@deborah.org",{"lat":229,"lon":230},39.97261,-74.58293,{"facility":232,"status":8,"city":233,"state":233,"zip":234,"country":95,"contacts":235,"geoPoint":240},"Mount Sinai","New York","10029",[236],{"name":237,"role":99,"phone":238,"email":239},"Samin Sharma","212-241-9687","samin.sharma@mountsinai.org",{"lat":241,"lon":242},40.71427,-74.00597,{"facility":244,"status":8,"city":245,"state":233,"zip":246,"country":95,"contacts":247,"geoPoint":252},"St. Francis Hospital","Roslyn","11576",[248],{"name":249,"role":99,"phone":250,"email":251},"Allen Jeremias, MD","516-562-6790","allen.jeremias@chsli.org",{"lat":253,"lon":254},40.79982,-73.65096,{"facility":256,"status":8,"city":257,"state":258,"zip":259,"country":95,"contacts":260,"geoPoint":265},"The Lindner Research Center at The Christ Hospital","Cincinnati","Ohio","45219",[261],{"name":262,"role":99,"phone":263,"email":264},"Jarrod Frizzell, MD","513-585-1777","Jarrod.Frizzell@thechristhospital.com",{"lat":266,"lon":267},39.12711,-84.51439,{"facility":269,"status":8,"city":270,"state":258,"zip":271,"country":95,"contacts":272,"geoPoint":277},"Ohio Health Research Institute","Columbus","43214",[273],{"name":274,"role":99,"phone":275,"email":276},"Arash Arshi, MD","614-262-6772","arash.arshi@ohiohealth.com",{"lat":278,"lon":279},39.96118,-82.99879,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":95,"contacts":285,"geoPoint":290},"Heart and Vascular Research at WellSpan Health","York","Pennsylvania","17403",[286],{"name":287,"role":99,"phone":288,"email":289},"Stewart Benton, MD","717-851-2441","sbenton@wellspan.org",{"lat":291,"lon":292},39.9626,-76.72774,{"facility":294,"status":8,"city":295,"state":296,"zip":297,"country":95,"contacts":298,"geoPoint":303},"Ascension Saint Thomas","Nashville","Tennessee","37205",[299],{"name":300,"role":99,"phone":301,"email":302},"Jimmy Kerrigan, MD","615-269-4545","jimmy.kerrigan@ascension.org",{"lat":304,"lon":305},36.16589,-86.78444,{"facility":307,"status":8,"city":308,"state":309,"zip":310,"country":95,"contacts":311,"geoPoint":316},"University of Washington","Seattle","Washington","98195",[312],{"name":313,"role":99,"phone":314,"email":315},"Kathleen Kearney, MD","206-221-9154","kakearney@cardiology.washington.edu",{"lat":317,"lon":318},47.60621,-122.33207,[320],{"name":321,"role":99,"phone":322,"email":323},"Darin R. Lerew","612-276-2716","darin.lerew@kardion.com",[325,329],{"name":326,"affiliation":327,"role":328},"Samin Sharma, MD","Icahn School of Medicine at Mount Sinai","STUDY_CHAIR",{"name":177,"affiliation":171,"role":328},[],[],{"nct_id":4,"conditions":333,"biomarkers":334},[19,21],[],{"nct_id":4,"found":15,"summary":336,"prompt_version":346},{"design":337,"status":338,"heading":339,"summary":340,"follow_up":341,"word_count":342,"commitments":343,"compensation":344,"drugs_mentioned":345},"This study plans to enroll 310 participants. You will be randomly assigned to receive one of two types of mechanical circulatory support devices.","completed","KARDION CORY P4 System for High-Risk PCI","This study is testing the KARDION CORY P4 System, a type of mechanical circulatory support device, during a high-risk PCI (Percutaneous Coronary Intervention - a procedure to open blocked heart arteries). The goal is to see how safe and effective this device is for people with coronary artery disease who need support during their procedure. You might be able to join if you are between 18 and 90 years old, have a heart pumping ability (LV ejection fraction) of less than 50%, and have complex coronary artery disease. The study will measure major heart events and device-related safety 30 days after the procedure. The current recruitment status is unclear.","Your safety and effectiveness outcomes will be measured 30 days after the procedure.",109,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]