[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523070":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention, BPA","EXPERIMENTAL","Will receive questionnaires, exercise testing and BPA at baseline, follow up with questionnaires and exercise testing will be done at 6,12 and 24 months.",[13],"Procedure: Balloon Pulmonary Angioplasty (BPA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control, no BPA","NO_INTERVENTION","Will receive questionnaires, exercise testing at baseline. Due to the crossover design, they will receive BPA at 6 months. Follow up with questionnaires and exercise testing will be done at 6,12 and 24 months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Balloon Pulmonary Angioplasty (BPA)","A balloon pulmonary angioplasty is a minimally invasive intervention procedure to remove blood clots from the pulmonary arteries.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Aleid Breuning, MD","CONTACT","0031204444444","a.m.breuning@amsterdamumc.nl",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Josien van Es, MD,PhD","j.vanes1@amsterdamumc.nl",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Amsterdam UMC","RECRUITING","Amsterdam","North Holland","1117","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.88969,52.37403,{"lat":47,"lon":46},[50],{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Josien van Es","MD PhD",[56],{"name":57,"class":58},"Trombosestichting Nederland","UNKNOWN","100523070","bpa-in-ctepd-without-ph-100523070",false,"NCT06090838","BPA in CTEPD Without PH","Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease Without or With Mild Pulmonary Hypertension","BALLOON","Inclusion Criteria:\n\n* acute pulmonary embolism at least 3 months prior to inclusion and adequately treated\n* persistent functional limitations: (New York Heart Association (NYHA) class ≥2)\n* persistent radiological perfusion defects: ≥ 3 segmental perfusion defects\n* CPET result with:\n\n  1. at least 2 of the following criteria:\n\n     * peak VO2 \\\u003C 80%;\n     * peak O2 pulse \\\u003C 80% of predicted;\n     * V'E\u002FV'CO2 @ nadir \\> 34;\n     * Vd\u002FVt increasing until peak exercise or peak Vd\u002FVt \\> 0;4;\n     * gradual drop of SpO2 of ≥ 3%;\n  2. these exercise findings cannot be explained otherwise 2. patients completed a pulmonary rehabilitation program of at least 8 weeks no longer than 2 months before randomization.\n\n     3\\. exercise tests were performed after the pulmonary rehabilitation program 4. age 18-80 years 5. Clinical Frailty Scale (CFS) score \\\u003C 5 (CFS is a 9-point scale that summarizes the overall level of fitness or frailty of an older adult) 6. written informed consent 7. prior treatment or restart therapeutic dose of anticoagulation treatment before randomization\n\n     Exclusion Criteria:\n     1. history of balloon pulmonalis angiography (BPA) or pulmonary endarterectomy\n     2. residual thrombi that are not eligible for BPA\n     3. major acute or chronic cardiopulmonary comorbidities with an expected impact on survival, exercise capacity and\u002For gas exchange, e.g. significant coronary heart disease, diastolic\u002Fsystolic heart failure, pulmonary hypertension (mPAP \\> 25 mmHg), severe chronic obstructive pulmonary disease (COPD) GOLD class ≥3, interstitial lung disease (ILD), disabling neuromuscular disease, malignancy\n     4. inability to undergo exercise tests\n     5. contrast allergy\n     6. creatinine clearance \\\u003C 30ml\u002Fmin\n     7. pregnancy or breastfeeding","ALL","18 Years","80 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to assess the effect of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic tromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH).\n\nThe main question\\[s\\] it aims to answer are:\n\n* What is the effect of BPA on quality of life, measured with the PEmb-QoL-questionnaire, in patients with CTEPD without PH?\n* What is the effect of is the effect of BPA on exercise capacity in patients with CTEPD without PH?\n\nThis study is a randomised clinical trial with cross-over design. Participants will be randomised in an intervention and a control group. At baseline, questionnaires and exercise tests will be perfomed in all patients. The intervention group will first receive BPA-treatment. After 6 months, all patients will fill in the questionaires and undergo the exercise tests. At this point the control group will also receive BPA-treatment. After 12 months the study outcomes will be measured in all participants with the same questionnaires and exercise tests. The total follow-up is 24 months.",[78],"Chronic Thromboembolic Disease","2023-10-18",{"date":81,"type":82},"2023-10-19","ACTUAL",{"date":84,"type":82},"2023-06-15",{"date":86,"type":72},"2027-10-31",{"name":5,"class":6},1]