[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VasoStar, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.",[26,27],"Chronic Total Occlusion of Coronary Artery","Chronic Angina","RECRUITING","2025-09-15",{"date":31,"type":32},"2025-09-16","ACTUAL",{"date":34,"type":32},"2024-06-10",{"date":36,"type":20},"2026-12-31",{"name":38,"class":39},"VasoStar, LLC","INDUSTRY",2,""]