[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CoreAalst BV\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100531900","the-complete-study-100531900",false,"NCT06205810","The COMPLETE Study","Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.","COMPLETE","Inclusion Criteria:\n\n1\\. Epicardial stenosis more than 50% by visual assessment.\n\nExclusion Criteria:\n\n1. STEMI.\n2. Hemodynamic instability.\n3. Rapid atrial fibrillation, flutter or arrhythmia (HR \\> 80 bpm).\n4. Insufficient CCTA image quality.\n5. Age \\\u003C18 years.\n6. Chronic obstructive pulmonary disease.\n7. Contraindication to adenosine.\n8. NYHA class III or IV, or last known left ventricular ejection fraction \\\u003C30%.\n9. Uncontrolled or recurrent ventricular tachycardia.\n10. History of recent stroke (≤90 days).\n11. Prior myocardial infarction.\n12. History of ischemic stroke (\\>90 days) with modified RANKIN score ≥ 2.\n13. History of any hemorrhagic stroke.\n14. Previous coronary artery bypass surgery.\n15. Active liver disease or hepatic dysfunction, defined as AST or ALT \\> 3 times the ULN.\n16. Severe renal dysfunction, defined as an eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n17. BMI \\>35 kg\u002Fm2.\n18. Nitrate intolerance\n19. Contra-indication to heart rate lowering drugs.\n20. Unable to provide written informed consent.","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","3 Years","OBSERVATIONAL","The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \\>50% stenosis on CCTA, patients eligible for the study will be invited to participate.\n\nThe main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.\n\nPatients will be divided into 2 sub-groups:\n\nCohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.\n\nCohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.\n\nIn both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.\n\nPatients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.",[26],"Coronary Artery Disease",[28],"FFRCT","RECRUITING","2026-01-16",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":33},"2023-10-24",{"date":37,"type":21},"2031-10-15",{"name":39,"class":40},"CoreAalst BV","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100585104","the-3d-stent-study-100585104","NCT06898021","The 3D Stent Study","Diagnostic Performance of 3DStent to Assess Stent Expansion","Inclusion Criteria:\n\n* Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Coronary lesions requiring total stent length \\> 48 mm.\n3. Body mass index \\>35 kg\u002Fm2\n4. Uncontrolled recurrent ventricular tachycardia\n5. Cardiogenic shock\n6. Unable to provide written informed consent (IC).",{"count":50,"type":21},200,"The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.\n\nThe main question it aims to answer is:\n\nThe study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.",[26,53],"Percutaneous Coronary Intervention (PCI)","2026-01-09",{"date":56,"type":33},"2026-01-12",{"date":58,"type":33},"2025-04-11",{"date":60,"type":21},"2027-12-31",{"name":39,"class":40},4,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100472900","phase-4-insightful-ffr-clinical-trial-100472900","NCT05437900","INSIGHTFUL-FFR Clinical Trial","Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization","Inclusion Criteria:\n\n1. The subject must be at least 18 years of age and younger than 85 years old.\n2. Eligible for elective PCI.\n3. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)\n4. Subject willing to participate and able to understand, read and sign the Informed Consent.\n\nExclusion Criteria:\n\n1. STEMI as clinical presentation.\n2. Chronic total occlusion as a target vessel.\n3. Significant contraindication to adenosine administration (e.g. heart block, severe asthma)\n4. Uncontrolled or recurrent ventricular tachycardia.\n5. Hemodynamic instability.\n6. Severe valvular disease.\n7. Severe renal dysfunction defined as an eGFR ≤30 mL\u002Fmin\u002F1.73 m2.\n8. Comorbidity with life expectancy ≤ 2 years.\n9. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.\n10. Planned major cardiac or non-cardiac surgery within 24 months after the index procedure. Note: major surgery is any invasive procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.\n11. Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre- medicated.\n12. The subject has received a functioning solid organ transplant or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.\n13. The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.\n14. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest\u002Fmediastinum.\n15. Subject has a platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3.\n16. The subject has a documented or suspected hepatic disorder defined as cirrhosis or Child-Pugh ≥ Class B.\n17. The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy of \\\u003C2 years for any non-cardiac cause.\n18. The subject is currently participating in another investigational drug or device clinical study.\n19. Pregnancy or nursing.\n20. Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements or impact the scientific soundness of the clinical investigation results.","85 Years",{"count":72,"type":21},2500,"INTERVENTIONAL",[75],"PHASE4","Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires.\n\nInsightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy\n\nAfter determining the presence of a coronary artery disease\u002F stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.",[26,78],"Acute Coronary Syndrome",[80],"Percutaneous Coronary intervention (PCI)",{"date":56,"type":33},{"date":83,"type":33},"2022-09-22",{"date":85,"type":21},"2030-06-30",{"name":39,"class":40},29,""]