[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525594":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":61,"centralContacts":73,"locations":81,"responsibleParty":95,"collaborators":98,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":31,"enrollmentInfo":112,"targetDuration":31,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":129,"whyStopped":31,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"4th Military Clinical Hospital with Polyclinic, Poland","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"CAS + Intravascular measuring the pressure gradient","EXPERIMENTAL","Patients with internal carotid stenosis qualified for angioplasty with stent implantation.\n\nStandard CAS procedure with additional intravascular pressure measurements",[13,14,15,16,17,18,19,20],"Procedure: CAS + Intravascular measuring the pressure gradient","Procedure: CAS (standard)","Diagnostic Test: Doppler ultrasonound of cephalic arteries","Radiation: Angio-CT of the neck and head","Other: Otolaryngological examination","Other: Psychological examination","Other: Neurological examination","Diagnostic Test: MR cerebral perfusion",{"label":22,"type":23,"description":24,"interventionNames":25},"CAS (standard)","ACTIVE_COMPARATOR","Patients with internal carotid stenosis qualified for angioplasty with stent implantation.\n\nStandard CAS procedure.",[14,15,16,17,18,19,20],[27,32,35,40,45,49,53,57],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Measurements taken during the procedure during CAS\n\n* placement of a \"FFR\"- micro catheter on the neuroprotection wire and taking a measurement before the stenosis and in the internal carotid artery above the stenosis\n* reading the pressure gradient after obtaining a stable value (a minimum of 5 cardiac cycles)\n\n  * the study of intravascular pressure measurements will be performed using a special micro catheter",[9],null,{"type":28,"name":22,"description":33,"armGroupLabels":34,"otherNames":31},"Animation of blood pressure measurements on the \"FFR\" console without actual measurement in carotid artery (\"blinding\" of the study to the patient) during CAS procedure.",[22,9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"DIAGNOSTIC_TEST","Doppler ultrasonound of cephalic arteries","non-invasive assessment of carotid stenosis before surgery and assessment of results after CAS (3 and 12 months after CAS)",[22,9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"RADIATION","Angio-CT of the neck and head","Non-invasive pre-operative assessment and post-CAS result (3 months after)",[22,9],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":31},"Otolaryngological examination","Hearing and balance tests (before and after CAS) - prospective follow-up",[22,9],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":31},"Psychological examination","psychological examination with questionnaires (before and after CAS) - prospective follow-up",[22,9],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":31},"Neurological examination","neurological examination with questionnaires (before and after CAS) - prospective follow-up",[22,9],{"type":36,"name":58,"description":59,"armGroupLabels":60,"otherNames":31},"MR cerebral perfusion","Assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS (after 3 months):\n\nParametric maps of cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and mean transit time (MTT) will be generated and used for the qualitative and quantitative analyses of the following perfusion parameters:\n\n* cerebral blood volume (CBV) value in ml\u002F100ml;\n* cerebral blood flow (CBF) value in ml\u002F100ml\u002Fmin;\n* mean transit time (MTT) value in seconds\n* time to peak (TTP) value in seconds",[22,9],[62,66,69,71],{"name":63,"affiliation":64,"role":65},"Krzysztof Ściborski, MD, PhD","4th Military Hospital in Wrocław","PRINCIPAL_INVESTIGATOR",{"name":67,"affiliation":64,"role":68},"Waldemar Banasiak, MD, PhD","STUDY_DIRECTOR",{"name":70,"affiliation":5,"role":68},"Artur Telichowski, MD, PhD",{"name":72,"affiliation":5,"role":68},"Adrian Doroszko, MD, PhD",[74,78],{"name":63,"role":75,"phone":76,"phoneExt":31,"email":77},"CONTACT","0048261660452","ksciborski@4wsk.pl",{"name":79,"role":75,"phone":31,"phoneExt":31,"email":80},"Natalia Świątoniowska-Lonc, MD, PhD","nlonc@4wsk.pl",[82],{"facility":83,"status":31,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":31},"4th Military Hospital","Wroclaw","Lower Silesian Voivodeship","50-981","Poland","PL",{"type":90,"coordinates":91},"Point",[92,93],17.03006,51.10286,{"lat":93,"lon":92},{"type":65,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Krzysztof Ściborski","Vice-Head of Cath Lab; Department of Cardiology, Center for Heart Disease, 4th Military Hospital, Wrocław, Poland",[99],{"name":100,"class":101},"Medical Research Agency, Poland","OTHER_GOV","100525594","innovative-application-of-pressure-gradient-measurement-in-internal-carotid-stenosis-in-patients-undergoing-cas-100525594",false,"NCT06123767","Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS","Evaluation of Diagnostic and Predictive Capabilities of Novel Application of Carotid Carotid Stenosis Pressure Gradient Measurement in Patients Undergoing Percutaneous Carotid Angioplasty and Stenting (CAS).","NOTICE-CAS","Inclusion Criteria:\n\n* Stenosis of the internal carotid artery in symptomatic patients: \\> 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Stenosis of the internal carotid artery in asymptomatic patients: \\>60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Age of patients: \\> 18 years of age\n* Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent to participate in the study.\n* Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).","ALL","18 Years",{"count":113,"type":114},200,"ESTIMATED","INTERVENTIONAL",[117],"NA","About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis.\n\nIn 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis.\n\nCarotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems.\n\nOBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit.\n\nPRIMARY ENDPOINTS:\n\n1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS\n2. Assessment of cognitive symptoms using before and after CAS\n3. Assessment of neurological symptoms before and after CAS\n4. Assessment of otolaryngological symptoms before and after CAS\n\nSECONDARY ENDPOINTS:\n\nCreation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis.\n\nA final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.",[120,121,122],"Carotid Artery Stenosis","Carotid Artery Stenting","Stroke",[124,125,126,120,127,128],"CAS (carotid artery stenting)","FFR (fractional flow reserve)","FFR-CT (Fractional Flow Reserve - Computed Tomography)","Functional assessment of the stenosis","Decision making algorithm","NOT_YET_RECRUITING","2024-03-05",{"date":132,"type":133},"2024-03-07","ACTUAL",{"date":135,"type":114},"2024-04-01",{"date":137,"type":114},"2027-07-31",{"name":5,"class":6},1]