[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-percutaneous-coronary-intervention-high-risk-pci\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-percutaneous-coronary-intervention-high-risk-pci":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"High-Risk Percutaneous Coronary Intervention (High-risk PCI)","RECRUITING","2026-04-24",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2025-07-25",{"date":36,"type":21},"2027-09-16",{"name":38,"class":39},"Magenta Medical Ltd.","INDUSTRY",29,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100597063","interventional-left-ventricular-assist-system-for-pci-in-chip-patients-100597063","NCT07053618","Interventional Left Ventricular Assist System for PCI in CHIP Patients","Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial","Inclusion Criteria:\n\n1\\. Aged 18-90 2. The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is considered high-risk or the subject refuses CABG. The investigator believes the subject may benefit from PCI (Percutaneous Coronary Intervention).\n\n3\\. Left ventricular ejection fraction (LVEF) ≤ 35%. 4. Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:\n\n1. Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).\n2. A last remaining patent coronary artery (the anterior descending artery (LAD) and\u002For its branches, the circumflex artery (LCX) and\u002For its branches, and the right coronary artery (RCA) and\u002For its branches).\n3. Saphenous vein graft (SVG) vascular lesions.\n4. Severely calcification, tortuosity.\n5. Multivessel disease (two or more) combined with chronic total occlusion (CTO).\n6. Three-vessel disease. Three-vessel disease is defined as significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and\u002For its branches, the left circumflex artery (LCX) and\u002For its branches, and the right coronary artery (RCA) and\u002For its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.\n\n5\\. Patients who are able to give informed consent and complete the follow-up.\n\nExclusion Criteria:\n\n1. Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP \\\u003C90 mmHg for ≥30 min or requiring supportive measures to maintain SBP \\>90 mmHg and end-organ hypoperfusion (urine output \\\u003C30 ml\u002Fh or cool extremities).\n2. STEMI or CK-MB did not return to the normal range within 24 hours.\n3. Cardiac arrest with cardiopulmonary resuscitation within 24 hours.\n4. Left ventricular mural thrombus.\n5. After aortic valve replacement surgery (mechanical, bioprosthetic).\n6. Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.\n7. Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.\n8. Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.\n9. Severe right heart failure or severe tricuspid valve insufficiency.\n10. Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.\n11. Severe peripheral arterial stenosis or occlusive lesions.\n12. Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin \\\u003C90 g\u002FL). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109\u002FL, INR ≥2.0, or fibrinogen ≤1.5 g\u002FL).\n13. Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.\n14. Active hemorrhage within 1 month.\n15. History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.\n16. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg\u002FdL (353.6 µmol\u002FL) within 7 days.\n17. Liver dysfunction: liver AST, ALT and bilirubin \\>3 times the upper limit of normal within 7 days.\n18. Presence or suspected presence of infective endocarditis or systemic infection.\n19. Women who are pregnant, breastfeeding, or planning pregnancy during the trial.\n20. Participation in another drug or medical device clinical trial.\n21. Other conditions deemed by the investigator as unsuitable for participation in this trial.\n\n    \\-","90 Years",{"count":50,"type":21},286,[24],"Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years.\n\nIn China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement.\n\nCommon pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients.\n\nThe aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.",[27,54],"Left Ventricular Assist Devices","2025-08-25",{"date":57,"type":32},"2025-08-26",{"date":59,"type":32},"2025-08-06",{"date":61,"type":21},"2027-08-01",{"name":63,"class":39},"Suzhou Hengruihongyuan Medical Technology Co. LTD",15]