[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568065":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":45,"responsibleParty":93,"collaborators":96,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":125,"whyStopped":26,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Hemiarch group (HAR)","ACTIVE_COMPARATOR","Under general anesthesia and transesophageal echocardiogram monitoring, a median sternotomy will be performed. Patients will be placed on cardiopulmonary bypass using arterial inflow from the femoral artery, axillary artery, or direct aortic cannulation, along with right atrial appendage venous cannulation. Systemic cooling to 25 degrees Celsius will commence, followed by thiopental coma and circulatory arrest. The aorta will be trimmed to the distal ascending aorta or proximal arch, and antegrade cerebral perfusion will be initiated to the brachiocephalic branch.\n\nThe distal anastomosis will connect a vascular graft to the distal ascending aorta or aortic arch. After completing this, systemic perfusion and rewarming will begin, followed by the proximal anastomosis with the vascular graft. After de-airing, the aorta will be de-clamped, and the patient will be weaned from cardiopulmonary bypass and decannulated. Hemostasis and sternal closure will follow standard institutional protocols",[13],"Procedure: Conventional hemiarch replacement",{"label":15,"type":10,"description":16,"interventionNames":17},"Total Arch Replacement and Frozen Elephant Trunk group (TARFET)","Under general anesthesia and transesophageal echocardiogram monitoring, a median sternotomy will be performed. Patients will be placed on cardiopulmonary bypass via femoral, axillary, or direct aortic cannulation. Systemic cooling to 25 degrees Celsius will lead to thiopental coma and circulatory arrest. The aorta will be trimmed to the distal arch, with antegrade cerebral perfusion initiated.\n\nDistal anastomosis will connect a vascular graft to the distal arch, followed by visceral perfusion, rewarming, and proximal anastomosis. After de-airing, the aorta will be de-clamped, and the patient will be weaned from bypass and decannulated. Hemostasis and sternal closure will follow standard protocols.\n\nArterial cannulation sites for HAR and TARFET will be determined by the surgeon based on the clinical scenario.",[18,19],"Procedure: E-vita® Open Neo; Artivion","Procedure: Thoraflex Hybrid; Terumo",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Conventional hemiarch replacement","Conventional open hemiarch replacement",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"E-vita® Open Neo; Artivion","E-vita® Open Neo is a hybrid stent graft system for aortic arch and descending thoracic aorta repair with Frozen Elephant Trunk Technique.",[15],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Thoraflex Hybrid; Terumo","The Thoraflex Hybrid is a device system designed to repair a weakened and bulging section (aneurysm) and\u002For a tear in the lining (dissection) of the aorta behind the heart (aortic arch). The system includes a polyester graft section that reinforces a weakened section of the blood vessel, a connected stented section (nitinol wire frame on polyester graft material) that holds the artery open, and a delivery catheter that is used to place the device. The polyester graft and stented sections are coated with a protein substance taken from animal body parts (gelatin) to seal the implant and prevent blood from leaking out.",[15],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Randolph Hung Leung Wong","CONTACT","+85235052622","wonhl1@surgery.cuhk.edu.hk",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Eunice Man Ki Lo","+85235052629","eunicelo@surgery.cuhk.edu.hk",[46,64,77],{"facility":47,"status":26,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital Vienna","Vienna","Austria","AT",{"type":52,"coordinates":53},"Point",[54,55],16.37208,48.20849,{"lat":55,"lon":54},[58,62],{"name":59,"role":38,"phone":60,"phoneExt":26,"email":61},"Marek Ehrlich","+43 (0)1 40400-69660","marek.ehrlich@meduniwien.ac.at",{"name":59,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":65,"status":26,"city":66,"state":26,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Prince of Wales Hospital","Hong Kong","HK",{"type":52,"coordinates":69},[70,71],114.17469,22.27832,{"lat":71,"lon":70},[74,75,76],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":37,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":78,"status":26,"city":79,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Siriraj Hospital - Mahidol University","Bangkok","Thailand","TH",{"type":52,"coordinates":83},[84,85],100.50144,13.75398,{"lat":85,"lon":84},[88,92],{"name":89,"role":38,"phone":90,"phoneExt":26,"email":91},"Worawong Slisatkorn","(662) 411-1426","worawong.sli@mahidol.ac.th",{"name":89,"role":63,"phone":26,"phoneExt":26,"email":26},{"type":63,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Randolph Wong","Professor and Chief of Division of Cardiothoracic Surgery, Department of Surgery",[97,99],{"name":98,"class":6},"University of Vienna",{"name":100,"class":6},"Mahidol University","100568065","total-arch-replacement-with-frozen-elephant-trunk-versus-hemiarch-replacement-in-the-management-of-acute-type-a-aortic-dissection-100568065",false,"NCT06676371","Total Arch Replacement With Frozen Elephant Trunk Versus Hemiarch Replacement in the Management of Acute Type A Aortic Dissection","Randomized Control Trial of Total Arch Replacement With Frozen Elephant Trunk Versus Conventional Hemiarch Replacement in Patients With Acute Type A Aortic Dissection (TARFET-TAAD)","TARFET-TAAD","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 type A aortic dissection with entry tear beyond ascending aorta.\n4. Patient not in coma\u002Firreversible end organ failure\u002Fcardiac massage for resuscitation\n\nExclusion Criteria:\n\n1. There is no identifiable entry tear in the aorta\n2. The ascending entry tear extends into aortic arch\n3. Patient has entry tear only in ascending aorta\n4. Patient with Type B 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":113,"type":114},150,"ESTIMATED","INTERVENTIONAL",[117],"NA","Acute Type A aortic dissection (ATAAD) and its complications are life-threatening conditions that cause more than 1400 hospital admissions and 300 deaths every year in Hong Kong and cause 172,927 deaths globally in 2019. There is an increasing trend in recent years.\n\nGiven the hyperacute presentation and complexity of the clinical manifestation with various mal-perfusion syndromes, the mortality of ATAAD remained high in all international reported registries and published series.\n\nConventional Hemiarch (HAR) replacement has been the gold standard procedure for ATAAD in most of cardiac surgical centers around the world because of the relative simplicity of the procedure. However, around 50-70% of patients were reported to develop distal anastomosis new entry after hemiarch procedure and for those with entry tear over aortic arch and distal mal-perfusion, hemiarch alone might not be able to solve the downstream problem. On the other hand, total arch replacement and frozen elephant trunk procedure (TARFET) is more complex, technically demanding procedure that could potentially cover\u002Fresect the arch entry tear and exclude tear over proximal descending thoracic aorta and, hence, solve the distal mal-perfusion syndrome. To date, there is no randomized control trial to answer whether HAR or TARFET procedure is superior in patients with ATAAD and entry tear is over the aortic arch or proximal descending thoracic aorta.\n\nWe plan to conduct a multi-center trial to recruit consecutive patients with ATAAD with entry tear beyond ascending aorta and randomized them, after informed consent, into either the conventional hemiarch replacement group (HAR) or total arch replacement and frozen elephant trunk (TARFET). The participating centers will collect pre- operative, intra-operative and post-operative clinical parameters for two groups of patients via REDCap system. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. The primary outcome is the 30-day mortality of the ATAAD patients with surgically treated by HAR versus TARFET approach. The secondary outcomes are the major adverse cardiovascular and cerebral events, post-op renal replacement therapy, re-exploration for bleeding and re-intervention within 30-days.\n\nThis study will be the world's first multi-center randomized control trial in ATAAD to compare the 30-day mortality of patients treated with HAR and TARFET. It could be a guideline-changing study for the treatment of ATAAD and its impact on the surgical approach to patients suffering from ATAAD.",[120],"Aortic Dissection Type A",[122,123,124],"Total Arch Replacement and Frozen Elephant Trunk (TARFET)","Conventional Hemiarch (HAR) replacement","Acute Type A aortic dissection (ATAAD)","NOT_YET_RECRUITING","2026-03-16",{"date":128,"type":129},"2026-03-18","ACTUAL",{"date":131,"type":114},"2026-10",{"date":133,"type":114},"2029-10",{"name":5,"class":6},3]