[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-pci\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-pci":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,81,110],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100537175","standby-cannulated-ecmo-for-high-risk-percutaneous-coronary-intervention-100537175",false,"NCT06274411","Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention","Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention","ECMO-READY","Inclusion Criteria:\n\n1. Clinicians decide to perform PCI during ECMO support.\n2. Age of ≥18\n3. Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)\n4. Informed consent\n\nExclusion Criteria:\n\n1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP \\>90mmHg)\n2. Presence of moderate to severe aortic insufficiency\n3. Severe peripheral vascular disease\n4. creatinine≥4mg\u002FdL\n5. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN\n6. History of recent (within 1 month) stroke or TIA\n7. Abnormal coagulation(defined as platelet count ≤50000\u002Fmm3 or Fibrinogen ≤1.50g\u002FL)\n8. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.","ALL","18 Years",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :\n\n• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI",[27,28],"ECMO","High-risk PCI",[27,30],"PCI","RECRUITING","2026-05-10",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":35},"2025-03-21",{"date":39,"type":21},"2026-12-01",{"name":41,"class":42},"Beijing Anzhen Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":43},"100635788","chip-cc-registry-a-prospective-multicenter-registry-of-complex-high-risk-pci-in-china-100635788","NCT07557238","CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China","A Prospective, Multicenter, Observational Registry to Evaluate Clinical Outcomes and Prognostic Factors in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention in China","CHIP-CC","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age 18 to 90 years.\n2. Willing and able to comply with the study protocol and data collection procedures, able to understand the purpose of the study, and willing to provide written informed consent.\n3. Considered by the heart team to have an indication for coronary revascularization but to be at high risk for coronary artery bypass grafting, or the patient declines coronary artery bypass grafting, and PCI is considered potentially beneficial after heart team evaluation.\n4. Left ventricular ejection fraction ≤35%, or left ventricular ejection fraction ≤40% with severe mitral regurgitation.\n5. Undergoing complex PCI with at least one of the following features:\n\n   * Unprotected left main coronary artery disease;\n   * PCI of the last remaining patent coronary artery;\n   * Three-vessel coronary artery disease;\n   * Calcified coronary lesion requiring rotational atherectomy;\n   * Chronic total occlusion requiring bilateral angiography or retrograde techniques.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Acute ST-segment elevation myocardial infarction within 1 week before enrollment.\n2. Cardiogenic shock, defined by all of the following:\n\n   * Systolic arterial blood pressure \\\u003C90 mmHg for ≥30 minutes, or need for vasopressors, inotropes, or mechanical circulatory support to maintain systolic arterial blood pressure ≥90 mmHg;\n   * Evidence of reduced cardiac output, such as cardiac index \\\u003C2.2 L\u002Fmin\u002Fm²;\n   * Evidence of end-organ hypoperfusion, including cold extremities, urine output \\\u003C30 mL\u002Fhour, altered mental status, or lactate \\>2 mmol\u002FL.\n3. Unable to complete the planned follow-up.\n4. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the registry.","90 Years",{"count":54,"type":21},1000,"2 Years","OBSERVATIONAL","This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China. Eligible patients will be adults with complex coronary artery disease and severely reduced left ventricular function, or reduced left ventricular function with severe mitral regurgitation, who are considered by the heart team to have an indication for coronary revascularization but are at high risk for coronary artery bypass grafting or decline surgical revascularization.\n\nThe registry will collect baseline clinical characteristics, coronary angiographic and procedural data, use of intravascular imaging or physiological assessment, revascularization strategy, mechanical circulatory support, peri-procedural complications, laboratory and echocardiographic data, and follow-up outcomes. The primary endpoint is all-cause mortality at 1 year after PCI. Secondary endpoints include major adverse cardiovascular events, cardiac death, myocardial infarction, target vessel revascularization, heart failure hospitalization, major bleeding, and quality-of-life measures. The study also aims to identify prognostic factors and develop a risk prediction model for patients undergoing CHIP-PCI.",[59,60,61],"Coronary Artery Disease","High Risk PCI","Percutaneous Coronary Intervention (PCI)",[63,64,65,59,66,67,68,69],"CHIP","complex high-risk PCI","Percutaneous Coronary Intervention","left ventricular dysfunction","mechanical circulatory support","clinical outcomes","real-world registry","NOT_YET_RECRUITING","2026-05-07",{"date":73,"type":35},"2026-05-12",{"date":75,"type":21},"2026-06-01",{"date":77,"type":21},"2029-12-31",{"name":79,"class":80},"Guofeng Gao","OTHER_GOV",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100622176","use-of-mechanical-left-ventricular-unloading-in-complex-higher-risk-indicated-procedures-100622176","NCT07380217","Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures","Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures","UNLOAD-CHIP","Inclusion Criteria:\n\n* Age ≥18 years AND\n* Multidisciplinary heart team consensus for high risk PCI +\u002F- MCS AND\n* Hemodynamically stable (SCAI A-B) AND\n* LVEF \\\u003C30% OR LVEF \\\u003C35% with moderate MR OR LVEF \\\u003C40% with severe MR AND\n* Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native).\n\nExclusion Criteria:\n\n* Contraindications for Pulsecath IVAC2L:\n\n  1. severe aortic regurgitation\n  2. known presence of an LV thrombus (contrast echo\u002FMRI)\n  3. Mechanical aorta valve prosthesis\n  4. severe aortic valve stenosis\n  5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device\n* Cardiogenic shock defined as either SCAI CSWG stage C-E\n* Patient is intubated and mechanically ventilated\n* Stroke \\\u003C3 months\n* Major bleeding event \\\u003C3 months\n* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy\n* Pregnancy, or suspected thereof.\n* BMI \\> 35\n* 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 study procedures.\n* Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention).",{"count":90,"type":21},98,[24],"If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual.\n\nDuring the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs.\n\nTo help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it.\n\nThis study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.",[28,94],"Coronary Artery Disease Risk High",[28,63,96,97,98,99],"Mechanical Circulatory Support","Pulsecath iVAC2L","Pulsecath","iVAC2L","2026-01-26",{"date":102,"type":35},"2026-02-02",{"date":104,"type":35},"2024-01-25",{"date":106,"type":21},"2027-03-01",{"name":108,"class":42},"Amsterdam UMC, location VUmc",8,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100574096","clinical-trial-of-ventiflow-lp-supporting-high-risk-percutaneous-coronary-interventionpci-100574096","NCT06754839","Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)","Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention","Inclusion Criteria:\n\n1. 18 Years to 90 Years\n2. The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI\n3. The subject is diagnosed with acute or chronic coronary syndrome, and\n\n   1. LVEF≤ 35% or\n   2. LVEF ≤ 40% and NYHA Classification is III or IV\n4. Informed consent\n5. The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.\n\n1\\. At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards\n\nComplex operations are defined as:\n\n1. Bifurcation lesions require treatment of dual branches (including stents and PTCA)\n2. Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)\n3. Severe distortion requires complex operations\n4. The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )\n\nExclusion Criteria:\n\n1. Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;\n2. Cardiopulmonary resuscitation within 24 hours;\n3. Patients who have had cardiogenic shock (systolic blood pressure \\\u003C 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;\n4. Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;\n5. Presence of aortic stenosis\u002Fcalcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;\n6. Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;\n7. Prior or current use of a persistent left ventricular assist device (LVAD), or use of IABP, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (such as Impella or Tandem Heart) within 7 days prior to surgery;\n8. History of stroke or transient ischemic attack within 1 month before surgery;\n9. Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;\n10. Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);\n11. Moderate and severe anemia (hemoglobin \\\u003C90g\u002FL); Subject has abnormalities in coagulation parameters that cannot be corrected (defined as platelet count ≤ 75×109\u002FL or INR ≥2.0 or fibrinogen ≤1.50g\u002Fl); or inability to be treated with antiplatelet agents and anticoagulants;\n12. Active visceral hemorrhage within 1 month;\n13. History of allergy to heparin, contrast media, etc.;\n14. Aortic abnormalities that preclude surgery, including aneurysms, extreme curvature, or calcification; or known severe arterial disease that precludes the trial, such as aortic dissection, Marfan syndrome, etc.;\n15. Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;\n16. Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;\n17. Pregnant women and lactating women;\n18. The subject has participated in other medical device clinical trials\u002Fdrug clinical trials during the same period;\n19. ECMO cannot be implanted or there are contraindications to its application and any other conditions that the investigator considers inappropriate to participate in this trial.",{"count":118,"type":21},250,[24],"The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.",[59,122,28],"Heart Failure",[28,124,125],"Percutaneous left ventricular assist device","heart failure","2024-12-23",{"date":128,"type":35},"2025-01-01",{"date":130,"type":21},"2024-12",{"date":132,"type":21},"2025-12",{"name":134,"class":135},"Suzhou Hearthill Medical Technology Co.,LTD","INDUSTRY"]