[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amplitude Vascular Systems, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632188","avs-pulse-intravascular-lithotripsy-pulse-ivl-to-open-vessels-with-calcific-walls-and-enhance-vascular-compliance-and-remodeling-for-coronary-artery-disease-100632188",false,"NCT07510438","AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease","AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study","POWER CAD I","Key Inclusion Criteria:\n\n* ≥ 18 years of age\n* Subjects with native coronary artery disease\n* Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months\n* The target lesion must be a single de novo coronary lesion\n* The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \\\u003C100% or Stenosis ≥50% and \\\u003C70% with evidence of ischemia\n* Lesion length must not exceed 44 mm\n\nKey Exclusion Criteria:\n\n* Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.\n* Subject has New York Heart Association (NYHA) class III or IV heart failure.\n* Subject has renal failure with serum creatinine \\>2.5 mg\u002FdL, or chronic dialysis.\n* Subject has a previous stent in the target vessel implanted within last six months.\n* Unprotected LMCA diameter stenosis \\>30%.\n* Target lesion has a myocardial bridge.\n* Target vessel is excessively tortuous, defined as the presence of 2 or more bends \\>90 degrees or 3 or more bends \\>75 degrees.\n* Evidence of aneurysm in target vessel within 10 mm of the target lesion.\n* Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.\n* Target lesion is a bifurcation with ostial diameter stenosis ≥30%.\n* Any previous stent within 10 mm of the target lesion.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.",[27],"Coronary Arterial Disease (CAD)",[29,30],"Intravascular Lithotripsy","IVL","RECRUITING","2026-05-14",{"date":34,"type":35},"2026-05-18","ACTUAL",{"date":37,"type":35},"2026-05-08",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Amplitude Vascular Systems, Inc.","INDUSTRY",2,""]