[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447717":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":53,"locations":64,"responsibleParty":93,"collaborators":95,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":25,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":25,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BPA group","ACTIVE_COMPARATOR","Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician.",[13],"Procedure: Balloon pulmonary angioplasty",{"label":15,"type":10,"description":16,"interventionNames":17},"PEA group","Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians.",[18],"Procedure: Pulmonary endarterectomy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Pulmonary endarterectomy","Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Balloon pulmonary angioplasty","Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.",[9],[31,35,38,41,44,47,50],{"name":32,"affiliation":33,"role":34},"Irene Lang, MD,Prof","Medical University of Vienna","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"Harm Jan Bogaard, MD, Prof.","Amsterdam University Medical Center",{"name":39,"affiliation":40,"role":34},"Marion Delcroix, MD, Prof.","KU Leuven",{"name":42,"affiliation":43,"role":34},"Marco Post, MD, Prof.","St. Antonius Hospital",{"name":45,"affiliation":46,"role":34},"Gregely Meszaros, MD","Pulmonary Hypertension Association Europe",{"name":48,"affiliation":49,"role":34},"Johanna Pepke-Zaba, MD, Prof.","Papworth Hospital NHS Foundation Trust",{"name":51,"affiliation":52,"role":34},"Christoph Wiedenroth, MD","Kerckhoff Klinik",[54,60],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Asger Andersen, MD, ass.prof.","CONTACT","40138052","0045","asger.andersen@clin.au.dk",{"name":61,"role":56,"phone":62,"phoneExt":25,"email":63},"Kristina Laut Matzen, RN,PhD","+4521673903","krlaut@clin.au.dk",[65,80],{"facility":66,"status":67,"city":68,"state":25,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Aarhus University Hospital","RECRUITING","Aarhus","Denmark","DK",{"type":72,"coordinates":73},"Point",[74,75],10.21076,56.15674,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":25,"phoneExt":25,"email":25},"Asger Andersen, PhD",{"facility":81,"status":67,"city":82,"state":25,"zip":25,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Royal Ppworth","Cambridge","United Kingdom","UK",{"type":72,"coordinates":86},[87,88],0.11667,52.2,{"lat":88,"lon":87},[91],{"name":92,"role":56,"phone":25,"phoneExt":25,"email":25},"Joanna Pepke-Zaba",{"type":94,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[96,97,98,100,101,103,104],{"name":52,"class":6},{"name":33,"class":6},{"name":49,"class":99},"OTHER_GOV",{"name":43,"class":6},{"name":102,"class":6},"Utrecht University",{"name":40,"class":6},{"name":105,"class":6},"Amsterdam UMC, location VUmc","100447717","bpa-vs-pea-in-cteph-100447717",false,"NCT05110066","BPA vs. PEA in CTEPH","Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial","GO-CTEPH","Inclusion Criteria:\n\n* Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology\u002FEuropean Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee\n* Written informed consent from the patient\n* Patient age \\>17 and \\\u003C80 years\n* Able to understand and follow instructions and to participate in the entire study period\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C12 months\n* Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension\n* Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.\n* Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\\*\n* Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women\n* Previous balloon pulmonary angioplasty or pulmonary endarterectomy","ALL","18 Years","79 Years",{"count":118,"type":119},139,"ESTIMATED","INTERVENTIONAL",[122],"NA","Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.\n\nSome patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.",[125],"Chronic Thromboembolic Pulmonary Hypertension","2024-04-26",{"date":128,"type":129},"2024-04-29","ACTUAL",{"date":131,"type":129},"2024-04-01",{"date":133,"type":119},"2028-04-01",{"name":5,"class":6},2]