[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503403":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":103,"collaborators":105,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":28,"enrollmentInfo":132,"targetDuration":28,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":28,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Renal artery stenting","ACTIVE_COMPARATOR","Percutaneous transluminal renal angioplasty with stent placement",[13,14,15,16],"Drug: Optimal medical therapy (OMT)","Diagnostic Test: Catheter-based angiography","Diagnostic Test: Measurement of translesional pressure gradients","Procedure: Renal artery stenting",{"label":18,"type":19,"description":18,"interventionNames":20},"Sham procedure","SHAM_COMPARATOR",[13,14,15,21],"Procedure: Sham (No Treatment)",[23,29,34,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Optimal medical therapy (OMT)","Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.",[9,18],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DIAGNOSTIC_TEST","Catheter-based angiography","Catheter-based angiography performed in accordance with the study protocol.",[9,18],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Measurement of translesional pressure gradients","Measurement of translesional pressure gradients performed in accordance with the study protocol.",[9,18],{"type":39,"name":9,"description":40,"armGroupLabels":41,"otherNames":28},"PROCEDURE","Renal artery stenting performed in accordance with the study protocol.",[9],{"type":39,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"Sham (No Treatment)","Sham procedure performed in accordance with the study protocol.",[18],[47],{"name":48,"affiliation":49,"role":50},"Mark Reinhard, MD, PhD","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":28,"email":56},"Sebastian Nielsen, MD","CONTACT","+45 23100484","sebane@rm.dk",{"name":48,"role":54,"phone":58,"phoneExt":28,"email":59},"+45 40460321","m.reinhard@dadlnet.dk",[61,77,90],{"facility":49,"status":62,"city":63,"state":28,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Aarhus N","8200","Denmark","DK",{"type":68,"coordinates":69},"Point",[70,71],10.17317,56.20367,{"lat":71,"lon":70},[74,75],{"name":53,"role":54,"phone":28,"phoneExt":28,"email":56},{"name":48,"role":54,"phone":28,"phoneExt":28,"email":76},"markrein@rm.dk",{"facility":78,"status":62,"city":79,"state":28,"zip":80,"country":65,"countryCode":66,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Rigshospitalet","Copenhagen","2100",{"type":68,"coordinates":82},[83,84],12.56553,55.67594,{"lat":84,"lon":83},[87],{"name":88,"role":54,"phone":28,"phoneExt":28,"email":89},"Jonas P Eiberg, MD, PhD","jonas.peter.eiberg@regionh.dk",{"facility":91,"status":62,"city":92,"state":28,"zip":93,"country":65,"countryCode":66,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Odense University Hospital","Odense C","5000",{"type":68,"coordinates":95},[96,97],10.39538,55.40841,{"lat":97,"lon":96},[100],{"name":101,"role":54,"phone":28,"phoneExt":28,"email":102},"Michael D Schultz, MD","michael.dyrehauge.schultz@rsyd.dk",{"type":104,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[106,107,109,110,112,114,116,118,120],{"name":49,"class":6},{"name":108,"class":6},"Rigshospitalet, Denmark",{"name":91,"class":6},{"name":111,"class":6},"Aalborg University Hospital",{"name":113,"class":6},"Gødstrup Hospital",{"name":115,"class":6},"Holbaek Sygehus",{"name":117,"class":6},"Amsterdam UMC",{"name":119,"class":6},"The Novo Nordic Foundation",{"name":121,"class":6},"The Augustinus Foundation, Denmark.","100503403","effects-of-percutaneous-transluminal-renal-angioplasty-of-atherosclerotic-renal-artery-stenosis-in-high-risk-patients-100503403",false,"NCT05834803","Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.","Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.","DAN-PTRAII","Inclusion Criteria:\n\n1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.\n2. In addition, at least one of the following high-risk clinical syndromes:\n\n   1. Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.\n   2. Rapidly declining kidney function with a reduction in estimated GFR of \\>5 mL\u002Fmin per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.\n   3. Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, \"flash\" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction \\\u003C40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.\n\nAll 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Treatment-resistant heart failure episodes presumed caused by renovascular disease.\n* Rapidly declining kidney function\u002Facute kidney failure approaching the need for dialysis presumed caused by renovascular disease.\n* Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.\n* Pregnancy or unknown pregnancy status in female of childbearing potential.\n* Kidney size \\\u003C7 cm (pole to pole length) supplied by target vessel.\n* Previous kidney transplant.\n* Previous PTRA treatment.\n* Presence of a renal artery stenosis not amenable for treatment with a stent.\n\nPatients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.\n\nPatients treated with renal artery stenting without randomization in the study period include patients with:\n\n1. Treatment-resistant heart failure episodes presumed caused by renovascular disease.\n2. Rapidly declining kidney function\u002Facute kidney failure approaching the need for dialysis presumed caused by renovascular disease.\n3. At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:\n\n   * a mean translesional gradient of ≥10 mm Hg, or\n   * a systolic translesional gradient of ≥20 mm Hg, or\n   * a renal fractional flow reserve (Pd\u002FPa) of ≤0.8","ALL","18 Years",{"count":133,"type":134},80,"ESTIMATED","INTERVENTIONAL",[137],"NA","The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on:\n\n* Blood pressure\n* Kidney function\n* Hospitalizations for heart failure",[140,141,142,143,144],"Renovascular Hypertension","Renovascular Hypertension With Renal Failure","Heart Failure","Renal Artery Stenosis Atherosclerotic","Percutaneous Transluminal Angioplasty","2026-04-20",{"date":147,"type":148},"2026-04-23","ACTUAL",{"date":150,"type":148},"2023-06-26",{"date":152,"type":134},"2027-06-01",{"name":5,"class":6},3]