[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gentuity, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"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":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25],"Anatomy","RECRUITING","2025-03-25",{"date":29,"type":30},"2025-03-30","ACTUAL",{"date":32,"type":30},"2023-02-13",{"date":34,"type":19},"2026-12",{"name":36,"class":37},"Gentuity, LLC","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100463243","physio-anatomy-clinical-data-collection-study-100463243","NCT05312164","Physio-Anatomy Clinical Data Collection Study","Inclusion Criteria:\n\n* Patients \\>18 years of age.\n* Patients provide written informed consent.\n* Clinical presentation consistent with suspected coronary disease.\n* Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.\n\nExclusion Criteria:\n\n* Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.\n* Contraindication for FFR examination or administration of vasodilators.\n* Bacteremia or sepsis.\n* Major coagulation system abnormalities.\n* Severe hemodynamic instability or shock.\n* Heart Failure NYHA Class IV.\n* Severe valvular heart disease.\n* Prior heart transplant.\n* Acute renal failure based on diagnostic practice of the treating physician at time of screening.\n* Patient is pregnant.\n* Patient is currently enrolled in another clinical study that may impact the results of this study.\n* Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their",{"count":46,"type":19},150,"OBSERVATIONAL","This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.",[50],"Coronary Stenosis","2025-03-19",{"date":53,"type":30},"2025-03-20",{"date":55,"type":30},"2022-03-14",{"date":57,"type":19},"2025-12-31",{"name":36,"class":37},6,""]