[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530989":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":59,"collaborators":61,"id":64,"slug":19,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":19,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"VasoStar, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VasoStar guidewire system","EXPERIMENTAL","The VasoStar guidewire system will be used to cross vascular occlusion lesions.",[13],"Device: VasoStar guidewire system",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Mihaela Plesa","CONTACT","440 266 8226","fvtinfo@frantzgroup.com",[27,45],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Emory University","RECRUITING","Atlanta","Georgia","30322","United States",{"type":35,"coordinates":36},"Point",[37,38],-84.38798,33.749,{"lat":38,"lon":37},[41,43],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":19},"William Nicholson, MD",{"name":42,"role":44,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"facility":46,"status":29,"city":47,"state":48,"zip":49,"country":33,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Summa Health","Akron","Ohio","44034",{"type":35,"coordinates":51},[52,53],-81.51901,41.08144,{"lat":53,"lon":52},[56,58],{"name":57,"role":23,"phone":19,"phoneExt":19,"email":19},"Kevin Silver, MD",{"name":57,"role":44,"phone":19,"phoneExt":19,"email":19},{"type":60,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[62],{"name":46,"class":63},"UNKNOWN","100530989",false,"NCT06193954","VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions","Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy","VST100","Inclusion Criteria:\n\n* Male or female, over 18 years of age, presenting with at least one ischemia inducing lesion in a native coronary artery that is refractory to standard guidewire crossing. Chronic total occlusion (CTO) is defined as 100% coronary blockage for over a 3-month duration documented either by prior catheterization or by clinical evaluation\n* Suitable candidate for non-emergent, coronary angioplasty\n* Documented de-novo or restenotic coronary chronic total occlusion defined as a lesion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing\n* Left ventricle ejection fraction \\> 20% within the last 12 months.\n* For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be \\> 300 sec\n* Chronic total occlusion in a non-tortuous arterial segment\n* Voluntarily sign a Patient Informed Consent Form specific to the study.\n* Physically and mentally willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* Successful target lesion crossing with a conventional wire system prior to enrollment\n* Prisoners.\n* Pregnancy\n* Patient has an active implantable.\n* Extensive dissection created by refractory guidewire\n* Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms)\n* Active infection\n* Uncontrolled Hypertension (Systolic blood pressure \\> 180 mm) at the time of the procedure\n* History of severe reaction to contrast media\n* Recent myocardial infarction (within 2 weeks)\n* In-stent target lesion\n* Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure\n* Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion\n* Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease\n* Participation in another investigational protocol at the time of the procedure","ALL","18 Years",{"count":74,"type":75},10,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.",[81,82],"Chronic Total Occlusion of Coronary Artery","Chronic Angina","2025-09-15",{"date":85,"type":86},"2025-09-16","ACTUAL",{"date":88,"type":86},"2024-06-10",{"date":90,"type":75},"2026-12-31",{"name":5,"class":6},2]