[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BrosMed Medical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,63,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100607328","a-post-market-study-of-drug-coated-peripheral-balloon-dilatation-catheter-in-treating-femoropopliteal-artery-stenosis-or-occlusive-lesions-100607328",false,"NCT07187128","A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.","Inclusion Criteria:\n\n1. Aged 18 to 85 years, gender not restricted;\n2. Rutherford grade 2 to 5\n3. Target lesions located in the superficial femoral artery (SFA) and\u002For proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:\n\n   * Diameter stenosis ≥70% by visual estimation or\n   * Chronic total occlusion (CTO)\n4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;\n5. The guidewire can successfully pass through the target lesion site within the vascular lumen;\n6. Agree to participate in this clinical study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment\n2. Type D or higher dissection occurring after target lesion predilation;\n3. Residual diameter stenosis \\>50% following target lesion predilation;\n4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;\n5. Abnormal function of vital organs (liver\u002Fkidney\u002Fbrain) deemed unsuitable for intervention by investigators;\n6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel\u002Fstructural analogs, or contrast agents;\n7. Patients currently undergoing dialysis or immunosuppressive therapy;\n8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;\n9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;\n10. Pregnancy or lactation women;\n11. Currently participation in other drug\u002Fmedical device clinical trials without completion;\n12. Patients deemed by the investigator to be unsuitable for participation in this study.","ALL","18 Years","85 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.",[26],"Femoropopliteal Artery Stenoses or Occlusive Lesions","NOT_YET_RECRUITING","2025-09-15",{"date":30,"type":31},"2025-09-22","ACTUAL",{"date":30,"type":20},{"date":34,"type":20},"2028-12-30",{"name":36,"class":37},"BrosMed Medical Co., Ltd","INDUSTRY",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100579316","efficacy-and-safety-of-sirolimus-coated-coronary-balloon-dilatation-catheter-for-de-novo-coronary-bifurcation-lesions-100579316","NCT06822712","Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions","A Prospective, Multicenter, Noninferiority, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcation Lesions","Inclusion Criteria:\n\nParticipants in this clinical trial must meet all of the following criteria:\n\nGeneral Inclusion Criteria\n\n1. Age ≥18 years and ≤80 years.\n2. Evidence of asymptomatic myocardial ischemia, or stable\u002Funstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.\n3. Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).\n4. Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo invasive imaging follow-up.\n\nAngiographic Inclusion Criteria\n\n1. A maximum of 2 vessels requiring treatment, with no more than 3 lesions in total.\n2. If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion.\n3. Successful interventional treatment of the non-target lesion prior to the target lesion.\n4. Only one true bifurcation lesion requiring treatment (Medina classification 1.1.1, 1.0.1, 0.1.1), with a diameter stenosis ≥70% (by visual estimation) at the ostium of the target lesion side branch.\n5. Successful pre-dilation\u002Fkissing balloon of the target lesion side branch, no dissection grade C or higher, residual stenosis ≤30% (by visual estimation) in the side branch lesion, and TIMI 3 flow.\n6. Suitable for PCI, with the main branch lesion of the target lesion planned for stent implantation without drug-coated balloon treatment, and the side branch lesion treated with a drug-coated balloon without stent implantation; it is recommended to perform kissing balloon dilation for both the main and side branches.\n7. Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length ≤38 mm.\n\nExclusion Criteria:\n\nIf a participant has any of the following conditions, they will be excluded from the study:\n\nGeneral Exclusion Criteria\n\n1. Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.\n2. Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).\n3. Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.\n4. Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.\n5. History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebral hemorrhage, cerebral infarction, or other cerebrovascular accidents (stroke) within the past 6 months.\n6. Known Allergies to Contrast Agents, Paclitaxel, Sirolimus, or Their Derivatives.\n7. Life Expectancy Less Than 12 Months.\n8. Poor Compliance: Participants who, in the investigator's judgment, are unlikely to adhere to the study requirements or are otherwise deemed unsuitable for inclusion.\n9. Participation in Other Ongoing Clinical Trials: Participants who have not reached the primary endpoint in other ongoing clinical trials.\n10. Pregnant or Lactating Women: Women who plan to conceive within 12 months or are unwilling to use effective contraception.\n\nAngiographic Exclusion Criteria\n\n1. Left Main Trunk and Its Bifurcation Lesions Requiring Treatment.\n2. Thrombus in the Target Lesion: Excessive tortuosity of the vessel, making it unlikely for the balloon to pass through the lesion.\n3. Total Occlusion in the Side Branch Lesion of the Target Lesion.\n4. Severe Calcification in the Side Branch Lesion of the Target Lesion: Lesions that cannot be pre-dilated or treated with double-balloon kissing dilation.\n5. In-Stent Restenosis in the Target Vessel (Including Both Main and Side Branches).\n6. Residual Stenosis \\>30% (by Visual Estimation) or Dissection Grade C or Higher After Pre-Dilation or Double-Balloon Kissing Dilation of the Side Branch Lesion of the Target Lesion.","80 Years",{"count":48,"type":20},250,[23],"Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions",[52],"Coronary Arterial Disease (CAD)","RECRUITING","2025-09-11",{"date":56,"type":31},"2025-09-17",{"date":58,"type":31},"2025-03-03",{"date":60,"type":20},"2026-06",{"name":36,"class":37},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":62},"100593719","bm-shockwave-devices-clinical-study-in-coronary-calcified-lesions-100593719","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.",{"count":71,"type":20},198,[23],"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.",[75],"Coronary Artery Disease",[77,78,79],"Coronary artery disease","shockwave therapy","Coronary calcified lesions","2025-07-22",{"date":82,"type":31},"2025-07-25",{"date":84,"type":31},"2025-06-27",{"date":86,"type":20},"2026-12-31",{"name":36,"class":37},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":62},"100589231","coronary-aspiration-catheter-clinical-trial-100589231","NCT06951724","Coronary Aspiration Catheter Clinical Trial","A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)","Inclusion Criteria:\n\n\\- General inclusion criteria\n\n1. Age 18-80 years old (inclusive);\n2. Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);\n3. Voluntary participation and signed written informed consent. Imaging Inclusion Criteria\n4. DSA image showed that the target lesion was in situ coronary artery lesion;\n5. Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;\n\nExclusion Criteria:\n\n\\- General exclusion criteria\n\n1. previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;\n2. Comorbid cardiogenic shock;\n3. severe renal failure or ongoing dialysis;\n4. severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);\n5. Failure of preoperative thrombolysis requiring remedial PCI;\n6. Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;\n7. Ischemic stroke within 3 months prior to surgery;\n8. Known allergy to anticoagulant and antiplatelet agents or contrast media;\n9. female subjects who are known to be pregnant or lactating;\n10. Participation or planned participation in other clinical studies of drugs or devices;\n11. other conditions that the investigator evaluates to be unsuitable for participation in this trial.\n\n    Imaging exclusion criteria\n12. Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;\n13. severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;\n14. the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);\n15. the presence of severe triple coronary artery lesions requiring revascularization.",{"count":96,"type":20},144,[23],"To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).",[100],"ST-segment Elevation Myocardial Infarction (STEMI)","2025-04-23",{"date":103,"type":31},"2025-04-30",{"date":105,"type":31},"2025-02-20",{"date":107,"type":20},"2026-06-30",{"name":36,"class":37},""]