[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519493":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemiarch-AMDS","ACTIVE_COMPARATOR","Patient with acute DeBakey I aortic dissection will be put on GA and conventional CPB. During circulatory arrest, the aorta will be trimmed to the level of the distal ascending or proximal arch The AMDS device will be implanted into the aortic arch and descending thoracic aorta. The distal anastomosis will be done between a vascular graft and the distal ascending aorta\u002Faortic arch including the AMDS device sewing cuff. After the distal anastomosis is completed, visceral and cerebral systemic perfusion and rewarming will be started. Proximal anastomosis will be performed and the patient will be weaned from cardiopulmonary bypass and decannulated.",[13],"Procedure: AMDS; Artivion, Atlanta, Georgia, US",{"label":15,"type":10,"description":16,"interventionNames":17},"Hemiarch-C","Patient with acute DeBakey I aortic dissection will be put on GA and conventional CPB. During circulatory arrest, the aorta will be trimmed to the level of the distal ascending or proximal arch The AMDS device will be implanted into the aortic arch and descending thoracic aorta. The distal anastomosis will be done between a vascular graft and the distal ascending aorta\u002Faortic arch as per routine. After the distal anastomosis is completed, visceral and cerebral systemic perfusion and rewarming will be started. Proximal anastomosis will be performed and the patient will be weaned from cardiopulmonary bypass and decannulated.",[18],"Procedure: Conventional hemiarch replacement",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","AMDS; Artivion, Atlanta, Georgia, US","Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, US) hybrid prosthesis which comprises a proximal sewing collar and a distal self-expanding nitinol un-covered stent.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional hemiarch replacement","Coventional open hemiarch replacement",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Randolph Wong","CONTACT","+85255699431","wonhl1@surgery.cuhk.edu.hk",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Jacky Ho","+85235052629","jackyho@surgery.cuhk.edu.hk",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Prince of Wales Hospital","RECRUITING","Hong Kong","000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],114.17469,22.27832,{"lat":52,"lon":51},[55,58],{"name":56,"role":33,"phone":57,"phoneExt":25,"email":35},"Randolph Wong, FRCS","+8685255699431",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":39},"Jacky Ho, FRCS",{"type":61,"investigatorFullName":32,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Professor and Chief of Division of Cardiothoracic Surgery, Department of Surgery","100519493","study-comparing-hemiarch-replacement-and-hemiarch-plus-stent-implantation-in-acute-aortic-dissection-100519493",false,"NCT06044259","Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection","Randomized Trial on Acutely Dissected Aorta Repair With Hemiarch Replacement With or Without Stent Implantation (RADAR Trial)","RADAR","Inclusion Criteria:\n\n1. Patient´s age is between 18 and 80 years.\n2. Patient is willing and able to give informed consent.\n3. Patient has acute DeBakey Type I and requires repair or replacement of damaged or diseased vessels of the ascending aorta.\n4. Patient not in coma\u002Firreversible end organ failure\u002Fcardiac massage for resuscitation, at the time of consent.\n\nExclusion Criteria:\n\n1. Patient has aortic arch diameter of more than 4.5 cm\n2. Patient has known connective tissue disease or genetically linked aortopathy\n3. Patient has entry tear more than 2 cm over aortic arch\n4. Patient with DeBakey Type II aortic dissection\n5. Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 2 years.\n6. Patient has any other medical, social, or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study.","ALL","18 Years","80 Years",{"count":75,"type":76},72,"ESTIMATED","INTERVENTIONAL",[79],"NA","Acute DeBakey type I aortic dissection (ATAD) is one of the most lethal surgical emergencies. The conventional operative strategy is hemiarch replacement under cardiopulmonary bypass support to replace the diseased segment of the ascending aorta. However, in patients with dissection involving the whole aortic arch and descending thoracic aorta, the presence of the persistently perfused false lumen can lead to late aneurysm formation and require a second-stage operation, and this reduces long-term survival. In the surgical literature, there is growing evidence that the presence of Distal Anastomosis New Entry (DANE), which is a new intimal defect related to the trauma created by surgical sutures, is associated with persistent perfusion of the false lumen, aortic size growth, and the need of re-operation. The Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, USA) is a hybrid prosthesis with a proximal sewing collar and distal nitinol self-expanding un-covered stent system designed to reduce the occurrence of DANE and hopefully depressurize the false lumen and lead to remodeling of the aortic wall.\n\nThe investigators plan to prospectively recruit consecutive patients with acute ascending thoracic aortic dissection patients (Excluding DeBakey II) and randomized them, after informed consent, into either the conventional hemiarch replacement group (Hemiarch-C) or the hemiarch replacement plus AMDS implantation group (Hemiarch-AMDS). The participating team will collect pre-operative, intra-operative and post-operative clinical and radiological parameters for two groups of patients. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. Complete DICOM image files of the CT scans will be evaluated by two independent fully qualified Radiologists. Our primary outcome is the radiological detection of DANE in Hemiarch-C and Hemiarch-AMDS groups within the 12-month follow-up period.\n\nThis study will be the world's first randomized control trial in ATAD to compare the prevalence of DANE in Hemiarch-C and Hemiarch-AMDS. It could be a guideline-changing study for the treatment of ATAD and its impact on the immediate survival, second-stage treatment, and long-term survival of patients suffering from ATAD.",[82],"Aortic Dissection",[84,85],"Hemiarch replacement","AMDS implantation","2025-09-24",{"date":88,"type":89},"2025-09-29","ACTUAL",{"date":91,"type":89},"2023-10-01",{"date":93,"type":76},"2027-09-30",{"name":5,"class":6},1]