[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612873":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"National Heart Centre Singapore","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SoniCracker IVL","EXPERIMENTAL",null,[13],"Device: Medical device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Medical device","The SoniCracker IVL is a rapid-exchange catheter with an effective length of 1420mm, with two radiopaque markers at the distal end and is coated with a hydrophilic coating from the distal tip to the wire exchange port to facilitate tracking and catheter delivery during use. The catheter lumen consists of a wire lumen, an inflation lumen, and two shockwave electrodes. The wire lumen allows passage of a 0.014\" guidewire to guide the catheter into and through the lesion. The inflation lumen is filled with a 50%\u002F50% mixture of physiological saline and contrast media to inflate and deflate the balloon. The electrode traverses the entire effective length of the catheter for lithotripsy treatment. The proximal end of the catheter features a hub with two ports, one for inflation\u002Fdeflation of the balloon, and the other for connecting the electrode wires to the Coronary intravascular lithotripsy therapy device.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yann Shan Keh","CONTACT","+ 65 6704 8963","keh.yann.shan@singhealth.com.sg",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Si Lin Lim","+65 6704 2268","lim.si.lin@nhcs.com.sg",[31],{"facility":32,"status":33,"city":34,"state":11,"zip":35,"country":34,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"National Heart Center Singapore","RECRUITING","Singapore","169609","SG",{"type":38,"coordinates":39},"Point",[40,41],103.85007,1.28967,{"lat":41,"lon":40},[44,46],{"name":22,"role":23,"phone":45,"phoneExt":11,"email":25},"93892179",{"name":22,"role":47,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51],{"name":52,"class":53},"Biosensor Interventional Technologies Pte Ltd","UNKNOWN","100612873","singapore-sonicracker-intravascular-lithotripsy-sing-ivl-study-100612873",false,"NCT07259239","SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study","Inclusion Criteria:\n\n1. Patients at age ≥ 21 years old.\n2. Patients undergoing elective\u002F planned PCI with at least moderate coronary calcification on angiography at the target lesion are eligible for enrolment. Moderate coronary calcification is defined as densities on only one side of the arterial wall prior to contrast injection. Severe calcification was defined as radiopacities on both sides of the arterial wall prior to contrast injection.\n3. Patients need to demonstrate evidence of either a 180 arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy.\n\nExclusion Criteria:\n\n1. Significant co-morbidities:\n\n   * Cardiac arrest\n   * Cardiogenic shock\n   * Collapse \u002F comatose \u002F semi-conscious states\n2. Patients requiring urgent or emergent PCI.\n3. Patients who are unable to provide consent.\n4. Patients who are pregnant.\n5. Breast-feeding women\n6. Any patients whom the Investigator deems unsuitable for the study (e.g., due to other medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study-related study procedures).","ALL","21 Years",{"count":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"NA","Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.",[70],"Cardiovascular Diseases",[72],"SING-IVL","2025-11-26",{"date":75,"type":76},"2025-12-02","ACTUAL",{"date":78,"type":76},"2025-09-30",{"date":80,"type":64},"2026-07",{"name":5,"class":6},1]