[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100341763":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":31,"locations":36,"responsibleParty":52,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":80,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Submaximal balloon angioplasty plus intensive medical therapy","EXPERIMENTAL","Endovascular intervention with submaximal balloon angioplasty",[13],"Device: Submaximal balloon angioplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Submaximal balloon angioplasty","An endovascular procedure involving inflation of a balloon catheter undersized to 50-75% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.",[9],null,[22,25,28],{"name":23,"affiliation":5,"role":24},"Sepideh Amin-Hanjani, MD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Adnan Siddiqui, MD","University at Buffalo",{"name":29,"affiliation":30,"role":24},"Tanya Turan, MD","Medical University of South Carolina",[32],{"name":23,"role":33,"phone":34,"phoneExt":20,"email":35},"CONTACT","216 286-8945","Sepideh.Hanjani@Uhhospitals.org",[37],{"facility":5,"status":20,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cleveland","Ohio","44106","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.69541,41.4995,{"lat":47,"lon":46},[50],{"name":23,"role":33,"phone":51,"phoneExt":20,"email":35},"216-286-8945",{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sepideh Amin-Hanjani","Professor, Vice-Chair Department of Neurosurgery, Case Western Reserve University","100341763","restoring-flow-by-revascularization-with-submaximal-angioplasty-in-hemodynamic-intracranial-atherosclerotic-stenosis-100341763",false,"NCT03729817","REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis","VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)","Inclusion:\n\n* Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial.\n* Hemodynamic compromise based on borderzone infarct pattern\\* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA\\*\\* for the posterior circulation (vertebral and basilar artery stenosis).\n* Target vessel with minimal nominal diameter of 2mm\n* Target length of stenosis \\\u003C18mm\n* Symptoms within 30 days of enrollment\n* Age ≥30 and ≤90 years old#\n* Able to provide informed consent\n\n  * \\*Sole or predominant borderzone infarct pattern of qualifying event, as defined by SAMMPRIS cohort analysis \\*\\*Low flow state as determined by optimized flow algorithm as defined by the VERiTAS Study\n  * #Those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).\n\nExclusion:\n\n* Major disabling stroke mRS \\>3; progressive or fluctuating deficit within 24 hours\n* Hemorrhagic infarction (based on CT) within 14 days of enrollment\n* Any large stroke (\\>5cm) to be at risk for hemorrhagic conversion\n* Any neurological disease which would confound follow-up assessment\n* Any co-morbid disease condition with \\\u003C12 month life expectancy\n* Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial\u002Fventricular thrombus, cardiomyopathy with EF\\\u003C25%, cardiac myxoma\n* Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease\n* Active bleeding diathesis, h\u002Fo major systemic hemorrhage within 30 days, active PUD, platelets\\\u003C100K (severe liver impairment (AST or ALT\\>3 x normal, cirrhosis)\n* Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process\n* Mori C classification of stenosis (i.e. diffuse lesion, extremely angulated \\>90⁰, excessive proximal tortuosity) Previous treatment of target lesion with stent, angioplasty or other mechanical device\n* Extracranial vertebral artery or carotid artery tortuosity, stenosis or occlusion prohibiting access to the target lesion (not exclusionary if does not prohibit access to target lesion)\n* Unable or unwilling to undergo MRI\n* Unable to undergo cerebral angiography\n* Pregnancy\n* Concurrent participation in another study which would conflict with the current study\n* Allergy or contraindication to aspirin or Plavix\n* Indication for warfarin or NOAC beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation)\n* Thrombolytic therapy within 24 hours","ALL","30 Years","90 Years",{"count":66,"type":67},159,"ESTIMATED","INTERVENTIONAL",[70],"NA","By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility\u002Fpivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.",[73,74,75,76,77],"Intracranial Atherosclerotic Disease","Stroke","Angioplasty, Balloon","Hemodynamics","Device Safety",[79,74,75,76,77],"Intracranial atherosclerotic disease","NOT_YET_RECRUITING","2025-11-03",{"date":83,"type":84},"2025-11-04","ACTUAL",{"date":86,"type":67},"2027-10",{"date":88,"type":67},"2032-10-31",{"name":5,"class":6},1]