[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522150":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Gentuity, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neurovascular Imaging","EXPERIMENTAL","Use of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter (\"Gentuity Neurovascular Imaging System\") as a diagnostic tool for intravascular imaging in the cerebrovasculature.",[13],"Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","HF-OCT Imaging System with Vis-M Micro-Imaging Catheter","Subjects undergo HF-OCT imaging of the desired intravascular segement",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Pedro Lylyk, MD","Clínica La Sagrada Familia","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Sharon Timberlake, MSHS","CONTACT","(617) 957-1434","stimberlake@gentuity.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Arjun Bhat, MD, MBA","(978) 202-4108","abhat@gentuity.com",[37],{"facility":24,"status":38,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Buenos Aires","C1428ARJ","Argentina","AR",{"type":44,"coordinates":45},"Point",[46,47],-58.37723,-34.61315,{"lat":47,"lon":46},[50],{"name":23,"role":29,"phone":51,"phoneExt":20,"email":52},"+54 11 4787-2220","info@lylyk.com.ar",{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100522150","clinical-feasibility-evaluation-of-the-gentuity-hf-oct-imaging-system-with-vis-m-micro-imaging-catheter-100522150",false,"NCT06078878","Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter","Inclusion Criteria:\n\n* Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure\n* Patients that present with a Modified Rankin Score (mRS) ≤3\n* Patients 18 years of age or older\n* Patients willing and able to provide written informed consent to participate in evaluation\n\nExclusion Criteria:\n\n* Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk\n* Pregnant\n* Patient has a known hypersensitivity to contrast media\n* Patients undergoing an urgent or emergent neurointerventional procedure\n* Patients that present with a Modified Rankin Score (mRS) ≥4\n* Patients that present with an unresolved spontaneous subarachnoid hemorrhage and\u002For intracranial hemorrhage\n* Participation in another clinical trial of an investigational drug or device\n* Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System","ALL","18 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.",[71],"Anatomy","2025-03-25",{"date":74,"type":75},"2025-03-30","ACTUAL",{"date":77,"type":75},"2023-02-13",{"date":79,"type":65},"2026-12",{"name":5,"class":6},1]