[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Keya Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"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":5},"100570790","the-safety-and-performence-of-shockpulse-10-in-patients-with-coronary-artery-calcification-100570790",false,"NCT06711822","The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification","Prospective, Multicenter, Single-group Clinical Trial Evaluating the Safety and Effectiveness of ShockPulse-10 in the Treatment of Coronary Artery Calcification","Key Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age;\n2. Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment;\n3. A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia;\n4. The target lesion is a primary, in situ coronary artery lesion;\n5. The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect);\n6. Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion;\n7. The target lesion site has moderate to severe calcification (meeting one of the following conditions)：\n\n   ① Angiography: Moderate calcification :clearer and more easily visible high-density shadows during cardiac pulsation; Severe calcification :clear high-density shadows both during and at rest;\n\n   ② IVUS calcium score ≥2 points for superficial intimal, deep medial, and mixed calcification;\n8. TIMI grade 3 in target vessel before registration (pre-dilation is allowed);\n\nKey exclusion Criteria:\n\n1. Left ventricular ejection fraction \\\u003C 40%；\n2. NYHA class III or IV heart failure；\n3. Patients with single coronary artery supply;\n4. Patients with evidence of dissection at the site of the lesion on imaging;\n5. The imaging suggests that the vascular pathway is tortuous, making it difficult for the pre-dilatation device to reach the target location or to be retrieved;\n6. Patients with active systemic infections;\n7. Patients with uncontrollable severe hypertension (systolic pressure \\> 180 mmHg or diastolic pressure \\> 110 mmHg);\n8. Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \\\u003C10g\u002FdL or platelet count \\\u003C80×10\\^9\u002FL);","ALL","18 Years",{"count":19,"type":20},205,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .",[26,27],"Coronary Arterial Disease (CAD)","Calcification; Heart","RECRUITING","2024-11-27",{"date":31,"type":32},"2024-12-02","ACTUAL",{"date":34,"type":32},"2024-07-01",{"date":36,"type":20},"2025-12-30",{"name":38,"class":39},"Keya Medical","INDUSTRY",""]