[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455824":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":40,"responsibleParty":389,"collaborators":391,"id":397,"slug":398,"hasResults":399,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":399,"sex":404,"minAge":405,"maxAge":12,"enrollmentInfo":406,"targetDuration":12,"studyType":409,"phases":410,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical Therapy","NO_INTERVENTION","Patients will be treated with standard medical therapy, i.e., antihypertensives, pulse-rate regulators, and pain medication.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Stent Therapy","ACTIVE_COMPARATOR","Patients will be treated with both standard medical therapy, in addition to placement of a thoracic endovascular aortic repair stent graft.",[18],"Device: TEVAR",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","TEVAR","A TEVAR stent graft will be placed in the descending aorta in order to cover the primary entry of the dissection.",[14],[26],"Thoracic aortic endovascular repair stent graft",[28,32],{"name":29,"affiliation":30,"role":31},"Jacob W Budtz-Lilly, MD PhD","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Kevin Mani, MD PhD","Uppsala University Hospital",[36],{"name":29,"role":37,"phone":38,"phoneExt":12,"email":39},"CONTACT","45 28147705","jacoblilly@clin.au.dk",[41,57,69,81,93,109,122,134,146,158,172,186,198,210,222,234,246,258,273,287,299,311,325,337,349,358,370,379],{"facility":42,"status":43,"city":44,"state":12,"zip":12,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Aalborg University Hospital","RECRUITING","Aalborg","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],9.9187,57.048,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":12,"phoneExt":12,"email":56},"Christian N Petersen, MD","chnp@rn.dk",{"facility":30,"status":43,"city":58,"state":12,"zip":59,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Aarhus","8200",{"type":48,"coordinates":61},[62,63],10.21076,56.15674,{"lat":63,"lon":62},[66],{"name":67,"role":37,"phone":68,"phoneExt":12,"email":39},"Jacob W Budtz-Lilly, MD, 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Hospital","Helsinki","Finland","FI",{"type":48,"coordinates":99},[100,101],24.93545,60.16952,{"lat":101,"lon":100},[104,106],{"name":105,"role":37,"phone":12,"phoneExt":12,"email":12},"Mikko Jormalainen, MD PhD",{"name":107,"role":108,"phone":12,"phoneExt":12,"email":12},"Patrick Björkman, MD PhD","SUB_INVESTIGATOR",{"facility":110,"status":111,"city":112,"state":12,"zip":12,"country":96,"countryCode":97,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Kuopio University Hospital","NOT_YET_RECRUITING","Kuopio",{"type":48,"coordinates":114},[115,116],27.67703,62.89238,{"lat":116,"lon":115},[119],{"name":120,"role":37,"phone":12,"phoneExt":12,"email":121},"Petri Saari, MD PhD","petri.saari@pshyvinvointialue.fi",{"facility":123,"status":111,"city":124,"state":12,"zip":12,"country":96,"countryCode":97,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Oulu University Hospital","Oulu",{"type":48,"coordinates":126},[127,128],25.46816,65.01236,{"lat":128,"lon":127},[131],{"name":132,"role":37,"phone":12,"phoneExt":12,"email":133},"Juho Kariniemi, MD PhD","juho.kariniemi@ppshp.fi",{"facility":135,"status":43,"city":136,"state":12,"zip":12,"country":96,"countryCode":97,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Tampere University Hospital","Tampere",{"type":48,"coordinates":138},[139,140],23.78712,61.49911,{"lat":140,"lon":139},[143],{"name":144,"role":37,"phone":12,"phoneExt":12,"email":145},"Velipekka Suominen, MD PhD","velipekka.suominen@pirha.fi",{"facility":147,"status":43,"city":148,"state":12,"zip":12,"country":96,"countryCode":97,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Turku University Hospital","Turku",{"type":48,"coordinates":150},[151,152],22.26869,60.45148,{"lat":152,"lon":151},[155],{"name":156,"role":37,"phone":12,"phoneExt":12,"email":157},"Veikko Nikulainen, MD PhD","vpjnik@utu.fi",{"facility":159,"status":43,"city":160,"state":12,"zip":12,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Landspitali University Hospital","Reykjavik","Iceland","IS",{"type":48,"coordinates":164},[165,166],-21.89541,64.13548,{"lat":166,"lon":165},[169],{"name":170,"role":37,"phone":12,"phoneExt":12,"email":171},"Oscar D Bermeo, MD","oscard@landspitali.is",{"facility":173,"status":111,"city":174,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Amsterdam University Medical Center (AUMC)","Amsterdam","Netherlands","NL",{"type":48,"coordinates":178},[179,180],4.88969,52.37403,{"lat":180,"lon":179},[183],{"name":184,"role":37,"phone":12,"phoneExt":12,"email":185},"Kak Khee Yeung, MD, PhD, prof.","k.yeung@amsterdamumc.nl",{"facility":187,"status":111,"city":188,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"University Medical Center Groningen (UMCG)","Groningen",{"type":48,"coordinates":190},[191,192],6.56667,53.21917,{"lat":192,"lon":191},[195],{"name":196,"role":37,"phone":12,"phoneExt":12,"email":197},"Jean-Paul de Vries, MD, PhD, prof.","j.p.p.m.de.vries@umcg.nl",{"facility":199,"status":43,"city":200,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Leiden University Medical Center (LUMC)","Leiden",{"type":48,"coordinates":202},[203,204],4.49306,52.15833,{"lat":204,"lon":203},[207],{"name":208,"role":37,"phone":12,"phoneExt":12,"email":209},"Joost van der Vorst, MD, PhD","j.r.van_der_vorst@lumc.nl",{"facility":211,"status":111,"city":212,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Maastricht University Medical Center (MUMC)","Maastricht",{"type":48,"coordinates":214},[215,216],5.68889,50.84833,{"lat":216,"lon":215},[219],{"name":220,"role":37,"phone":12,"phoneExt":12,"email":221},"Barend Mees, MD, PhD, prof.","barend.mees@mumc.nl",{"facility":223,"status":111,"city":224,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Radboud University Medical Center (Radboudumc)","Nijmegen",{"type":48,"coordinates":226},[227,228],5.85278,51.8425,{"lat":228,"lon":227},[231],{"name":232,"role":37,"phone":12,"phoneExt":12,"email":233},"Mark Dirven, MD","mark.dirven@radboudumc.nl",{"facility":235,"status":111,"city":236,"state":12,"zip":12,"country":175,"countryCode":176,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Erasmus Medical Center (EMC)","Rotterdam",{"type":48,"coordinates":238},[239,240],4.47917,51.9225,{"lat":240,"lon":239},[243],{"name":244,"role":37,"phone":12,"phoneExt":12,"email":245},"Jorg de Bruin, MD, 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Hospital","Oslo",{"type":48,"coordinates":277},[278,279],10.74609,59.91273,{"lat":279,"lon":278},[282,285],{"name":283,"role":37,"phone":12,"phoneExt":12,"email":284},"Eric J Dorenberg, MD PhD","edorenbe@ous-hf.no",{"name":286,"role":31,"phone":12,"phoneExt":12,"email":12},"Beate R Lindberg, MD",{"facility":288,"status":43,"city":289,"state":12,"zip":12,"country":261,"countryCode":262,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"University Hospital Nord","Tromsø",{"type":48,"coordinates":291},[292,293],18.95508,69.6489,{"lat":293,"lon":292},[296],{"name":297,"role":37,"phone":12,"phoneExt":12,"email":298},"Knut E Kjørstad, MD PhD","knut.eivind.kjorstad@unn.no",{"facility":300,"status":43,"city":301,"state":12,"zip":12,"country":261,"countryCode":262,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"St Olavs Hospital","Trondheim",{"type":48,"coordinates":303},[304,305],10.39506,63.43049,{"lat":305,"lon":304},[308],{"name":309,"role":37,"phone":12,"phoneExt":12,"email":310},"Martin E Altreuther, MD PhD","Martin.Altreuther@stolav.no",{"facility":312,"status":43,"city":313,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"Sahlgrenska University Hospital","Gothenburg","Sweden","SE",{"type":48,"coordinates":317},[318,319],11.96679,57.70716,{"lat":319,"lon":318},[322],{"name":323,"role":37,"phone":12,"phoneExt":12,"email":324},"Sofia Stromberg, MD PhD","sofia.stromberg@vgregion.se",{"facility":326,"status":43,"city":327,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Linköping University Hospital","Linköping",{"type":48,"coordinates":329},[330,331],15.62157,58.41086,{"lat":331,"lon":330},[334],{"name":335,"role":37,"phone":12,"phoneExt":12,"email":336},"Robert Lind, MD","robert.lind@regionostergotland.se",{"facility":338,"status":43,"city":339,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Skånes University Hospital","Malmö",{"type":48,"coordinates":341},[342,343],13.00073,55.60587,{"lat":343,"lon":342},[346],{"name":347,"role":37,"phone":12,"phoneExt":12,"email":348},"Nuno Dias, MD, PhD","nuno.dias@med.lu.se",{"facility":350,"status":351,"city":352,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":353,"geoPoint":357,"contacts":12},"Örebro University Hospital","ACTIVE_NOT_RECRUITING","Örebro",{"type":48,"coordinates":354},[355,356],15.2066,59.27412,{"lat":356,"lon":355},{"facility":359,"status":43,"city":360,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"Karolinska University Hospital","Stockholm",{"type":48,"coordinates":362},[363,364],18.06871,59.32938,{"lat":364,"lon":363},[367],{"name":368,"role":37,"phone":12,"phoneExt":12,"email":369},"Rebecka Hultgren, MD, PhD","rebecka.hultgren@ki.se",{"facility":371,"status":43,"city":360,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":372,"geoPoint":374,"contacts":375},"Sodersjukhuset",{"type":48,"coordinates":373},[363,364],{"lat":364,"lon":363},[376],{"name":377,"role":37,"phone":12,"phoneExt":12,"email":378},"Johnny Steuer, MD, PhD","johnny.steuer@regionstockholm.se",{"facility":34,"status":43,"city":380,"state":12,"zip":12,"country":314,"countryCode":315,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"Uppsala",{"type":48,"coordinates":382},[383,384],17.63889,59.85882,{"lat":384,"lon":383},[387],{"name":33,"role":37,"phone":12,"phoneExt":12,"email":388},"kevin.mani@uu.se",{"type":390,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[392,395],{"name":393,"class":394},"The Swedish Research Council","OTHER_GOV",{"name":396,"class":6},"Swedish Heart Lung Foundation","100455824","scandinavian-trial-of-uncomplicated-aortic-dissection-therapy-100455824",false,"NCT05215587","Scandinavian Trial of Uncomplicated Aortic Dissection Therapy","SUNDAY","Inclusion Criteria:\n\nAll subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration.\n\nExclusion Criteria:\n\n* Subjects with no signed informed consent.\n* Subjects presenting with a complicated type B aortic dissection according to the above definition.\n* Subjects previously treated in their descending aorta, either open surgery or TEVAR.\n* Subjects with pre-existing thoracoabdominal aortic aneurysm.\n* Subjects with other aortic pathology with an indication for intervention that requires TEVAR.\n* Subjects with traumatic aortic dissections.\n* Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome.\n* Subjects with a clinically estimated life expectancy \\\u003C 2 years.\n* Subjects with dementia.\n* Pregnant or nursing subjects.\n* Subjects with current sepsis.\n* Subjects currently participating in other clinical interventional trials.","ALL","18 Years",{"count":407,"type":408},554,"ESTIMATED","INTERVENTIONAL",[411],"NA","The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for \"complicated\" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of \"uncomplicated\" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vascular Surgery.\n\nThis randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.\n\nSample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.",[414],"Aortic Dissection",[416],"Aortic; dissection; TEVAR; endovascular; vascular","2025-08-08",{"date":419,"type":420},"2025-08-11","ACTUAL",{"date":422,"type":420},"2023-05-24",{"date":424,"type":408},"2030-12-31",{"name":5,"class":6},28]