[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-coarctation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-coarctation":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636649","correlation-of-cardiac-index-measured-by-the-pram-method-with-nirs-and-lactate-levels-in-pediatric-aortic-coarctation-surgery-100636649",false,"NCT07568431","Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery","Correlation of Cardiac Index Measured by the Pressure Recording Analytical Method (PRAM) With Near-Infrared Spectroscopy (NIRS) and Arterial Lactate Levels in Neonates and Infants Undergoing Surgical Repair of Aortic Coarctation: A Prospective Observational Study","MostCare-Ped","Inclusion Criteria:\n\n* Neonates and infants planned for surgical repair of aortic coarctation\n* Body weight between 2.5 and 3.5 kg\n* Postnatal age between 0 and 3 months\n* Considered hemodynamically stable for anesthesia and surgery\n* Written informed consent obtained from legal guardians\n\nExclusion Criteria:\n\n* Severe multiorgan dysfunction\n* Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome)\n* Surgery requiring cardiopulmonary bypass\n* Preoperative metabolic acidosis or sepsis\n* Inability to obtain informed consent from legal guardians","ALL","3 Months",{"count":20,"type":21},43,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral\u002Frenal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.",[25,26],"Aortic Coarctation","Cardiac Output, Low",[28,29,30,31,32,25],"PRAM","Near-Infrared Spectroscopy","Cardiac Index","Pediatric Cardiac Surgery","Lactate","NOT_YET_RECRUITING","2026-04-28",{"date":36,"type":37},"2026-05-05","ACTUAL",{"date":39,"type":21},"2026-05",{"date":41,"type":21},"2027-03",{"name":43,"class":44},"Konya City Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100579782","minima-stent-system-post--approval-study-pas-100579782","NCT06828770","Minima Stent System Post- Approval Study (PAS)","Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children","Inclusion Criteria:\n\n* The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent\n* Indicated for treatment with the Minima Stent System per the IFU.\n\nExclusion Criteria:\n\n* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation\n* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation\n* Aortic or pulmonary artery aneurysm in the location targeted for treatment\n* Body weight \\\u003C 1.5 kg\n* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent\n* Target vessels larger or smaller than the Minima System balloon size ranges\n* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc\n* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.\n* Currently participating in an investigational drug study or another device study\n* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months\n* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and\u002For antithrombotic medications\n* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated",{"count":54,"type":21},100,"This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.",[57,25],"Pulmonary Artery Stenosis",[59,60,61,62,63,64,65],"Vascular Stenosis","Minima","Minima Stent","Minima Stent System","Renata Medical","Renata","infant stent","RECRUITING","2025-10-21",{"date":69,"type":37},"2025-10-23",{"date":71,"type":37},"2025-05-21",{"date":73,"type":21},"2031-12",{"name":63,"class":75},"INDUSTRY",15,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":45},"100574424","electronic-archive-of-patients-with-diagnosis-and-suspected-prenatal-diagnosis-of-aortic-coarctation-100574424","NCT06759103","Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation","ACOAP","Inclusion Criteria:\n\n* Patients with pre-natal or post-natal diagnosis of aortic coarctation from 01 January 2000 until approval (retrospective phase) and from approval until 31 December 2026 (prospective phase)\n\nExclusion Criteria:\n\n* Patients whose diagnosis of aortic coarctation is postnatal, considered to be \\>1 month after birth\n* prenatal diagnosis of genetic disease (e.g., Turner's Sdr)\n* coarctation in the setting of complex congenital heart disease",{"count":85,"type":21},150,"The purpose of this prosective and retrospective observational study is to analyze the clinical and echocardiographic characteristics of infants with prenatal diagnosis of suspected aortic coarctation (CoAo) in order to identify clinical and instrumental elements that can predict the risk of developing aortic coarctation in the neonatal period so that we can identify patients who are at high risk and would therefore require intensive care and observation; compared with low-risk patients, for whom early discharge would be evaluable.",[25],"2024-12-30",{"date":90,"type":37},"2025-01-06",{"date":92,"type":37},"2021-03-01",{"date":94,"type":21},"2026-12-31",{"name":96,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100572991","aortic-stiffness-by-cmr-in-aortic-coarctation-100572991","NCT06740461","Aortic Stiffness by CMR in Aortic Coarctation","The Correlation Between Ambulatory Blood Pressure Control and Aortic Stiffness Index Assessed by CMR After Aortic Coarctation Stenting in Adults","Patient criteria Inclusion criteria All patients with native or recurrent aortic coarctation between the age of 14 years and older.\n\nTranscatheter systolic gradient ≥ 20 mm Hg, body weight ≥ 20 kg, and normal LV ejection fraction (EF).\n\nExclusion criteria Patients with obstructive lesion of LVOT or aortic valve dysfunction greater than moderate (requiring surgical intervention).\n\nIrregular cardiac rhythm. Patients with other causes of secondary hypertension. Contraindications to CMR: Any contraindications to undergoing CMR, such as implanted metallic devices incompatible with MRI, severe claustrophobia.\n\nUnicuspid aortic valve Associated complex congenital heart defects (aside from simple septal defects and patent ductus arteriosus) Genetic syndromes Connective tissue disorder History of surgery involving the aortic root or ascending aorta.","14 Years","60 Years",{"count":107,"type":21},30,"This study investigates the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting, using cardiac magnetic resonance (CMR) imaging.",[25],[111,112,113,114],"Aortic coarctation","Aortic stiffness","CMR","Ambulatory blood pressure","2024-12-17",{"date":117,"type":37},"2024-12-18",{"date":119,"type":21},"2024-12",{"date":121,"type":21},"2027-12",{"name":123,"class":44},"Assiut University"]