[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530989":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":19,"enrollmentInfo":75,"targetDuration":19,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"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",[27,46],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Emory University","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-84.38798,33.749,{"lat":39,"lon":38},[42,44],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},"William Nicholson, MD",{"name":43,"role":45,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"facility":47,"status":29,"city":48,"state":49,"zip":50,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Summa Health","Akron","Ohio","44034",{"type":36,"coordinates":52},[53,54],-81.51901,41.08144,{"lat":54,"lon":53},[57,59],{"name":58,"role":23,"phone":19,"phoneExt":19,"email":19},"Kevin Silver, MD",{"name":58,"role":45,"phone":19,"phoneExt":19,"email":19},{"type":61,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[63],{"name":47,"class":64},"UNKNOWN","100530989","vasostar-vibrational-guidewire-system-to-facilitate-crossing-coronary-artery-chronic-total-occlusions-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":76,"type":77},10,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.",[83,84],"Chronic Total Occlusion of Coronary Artery","Chronic Angina","2025-09-15",{"date":87,"type":88},"2025-09-16","ACTUAL",{"date":90,"type":88},"2024-06-10",{"date":92,"type":77},"2026-12-31",{"name":5,"class":6},2]