[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593719":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":28,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"BrosMed Medical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group","EXPERIMENTAL",null,[13],"Device: BM shockwave devices",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","BM shockwave devices","Use the BM shockwave devices for pre-treatment of coronary calcification lesions.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Wang Yan, Professor","CONTACT","0592-968120","wy@medmail.com.cn",{"name":27,"role":23,"phone":24,"phoneExt":11,"email":25},"Wang Yan",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Xiamen University Affiliated Cardiovascular Hospital","RECRUITING","Fujian","Xiamen","361000","China","CN",{"type":38,"coordinates":39},"Point",[40,41],106.12972,28.92651,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":11,"phoneExt":11,"email":11},"Wang Yan, Ph.",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100593719","bm-shockwave-devices-clinical-study-in-coronary-calcified-lesions-100593719",false,"NCT07010094","BM Shockwave Devices Clinical Study in Coronary Calcified Lesions","A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions","Inclusion Criteria:\n\n* General inclusion criteria:\n\n  1. Age 18-85 years, male or female;\n  2. Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;\n  3. Patient is able and willing to comply with all assessments in the study.\n\nAngiography inclusion criteria:\n\n1. The target lesion is a de novo, in-situ coronary artery lesion;\n2. The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);\n3. The target lesion diameter stenosis is visually estimated to be ≥70%, or \\\u003C70% but ≥50% with evidence of ischemia;\n4. Clear high-density calcification shadows are visible both during cardiac contraction and at rest;\n5. Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted);\n6. The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion;\n7. Patients suitable for treatment with metal stent implantation.\n\nExclusion Criteria:\n\n* General exclusion criteria:\n\n  1. ST-segment elevation myocardial infarction within 3 days prior to the procedure;\n  2. Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;\n  3. New York Heart Association (NYHA) functional class III or IV;\n  4. Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;\n  5. Uncontrolled severe hypertension (persistent: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg);\n  6. Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine \\>2.5 mg\u002FdL (221 μmol\u002FL), or chronic kidney failure requiring long-term dialysis;\n  7. Platelet count \\\u003C60 × 10⁹\u002FL;\n  8. Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;\n  9. Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;\n  10. Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;\n  11. Patients with a life expectancy of less than 12 months due to severe medical conditions;\n  12. Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;\n  13. Pregnant or breastfeeding women;\n  14. Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.\n\nContrast exclusion criteria:\n\n1. The target lesion and non-target lesion are in the same vascular branch;\n2. The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;\n3. A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;\n4. The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;\n5. The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)\u002FRIMA (right internal mammary artery) bypass graft;\n6. An aneurysm is present within 10 mm of the target lesion;\n7. Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device;\n8. The target lesion has definite thrombus formation;\n9. The investigator determines that the target lesion is not suitable for vascular dilation in the patient.","ALL","18 Years","85 Years",{"count":59,"type":60},198,"ESTIMATED","INTERVENTIONAL",[63],"NA","This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.",[66],"Coronary Artery Disease",[68,69,70],"Coronary artery disease","shockwave therapy","Coronary calcified lesions","2025-07-22",{"date":73,"type":74},"2025-07-25","ACTUAL",{"date":76,"type":74},"2025-06-27",{"date":78,"type":60},"2026-12-31",{"name":5,"class":6},1]