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