[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DK Medical Technology (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,72],{"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":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624920","coronary-artery-drug-coated-balloon-dilatation-catheter-clinical-trial-protocol-100624920",false,"NCT07415902","Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol","A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions","Inclusion Criteria:\n\n* Age: ≥18 years old, regardless of gender;\n* Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;\n* Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.\n\nExclusion Criteria:\n\n* Residual stenosis \\>30% after pre-treatment with type C or higher dissection;\n* A history of cardiogenic shock;\n* Severe congestive heart failure or NYHA class IV severe heart failure;\n* Pregnant or lactating women;\n* Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).","ALL","18 Years",{"count":19,"type":20},252,"ESTIMATED","OBSERVATIONAL","This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.",[24],"In-Stent Restenosis or De Novo Coronary Artery Lesions",[26,27,28],"Coronary Artery Drug-Coated Balloon Dilatation Catheter","In-Stent Restenosis","De Novo Coronary Artery Lesions","NOT_YET_RECRUITING","2026-02-10",{"date":32,"type":33},"2026-02-17","ACTUAL",{"date":35,"type":20},"2026-02-28",{"date":37,"type":20},"2028-12",{"name":39,"class":40},"DK Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100554792","scoring-balloon-and-high-pressure-balloon-in-the-treatment-of-arteriovenous-graft-stenosis-100554792","NCT06503692","Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis","A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis","DKTAVG","Inclusion Criteria:\n\n1. Hemodialysis patients aged ≥18 and ≤80 years old, (Note: Hemodialysis patients in Singapore aged ≥ 21 and ≤80 years old);\n2. AVG is mature and has successfully completed at least one hemodialysis treatment;\n3. The target lesion is located in the AVG return vein and the venous side anastomosis;\n4. The degree of stenosis of the target lesion is ≥50% (DSA visual inspection), and one of the following clinical indicators exists at the same time: Physical examination abnormalities include: open collateral veins, ipsilateral limb edema, changes in pulse characteristics, abnormal tremors, abnormal murmurs, etc.; Dialysis abnormalities include: increased venous pressure, new puncture difficulties, aspiration of thrombi, inability to reach target dialysis blood flow, prolonged haemostasis time after needle removal for 3 consecutive times, unexplained decrease in dialysis dose Kt\u002FV (\\>0.2 units), decrease in brachial artery blood flow (brachial artery blood flow \\\u003C650ml\u002Fmin or decreased by 20% compared with the previous follow-up visit), etc.\n5. The target lesion is primary or restenotic, consisting of one or more series of lesions, and the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤80mm ;\n6. The patient voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. The target lesion is located in the feeding artery, arterial anastomosis, artificial blood vessel puncture site, cephalic venous arch, thoracic outlet or central vein;\n2. A stent has been implanted in any part of the access or there is ipsilateral central vein stenosis or occlusion that affects the function of the access;\n3. Severely calcified lesions that are not expected to be dilatable with balloons;\n4. Acute thrombosis or chronic total occlusion of AVG occurred at the time of enrolment;\n5. The target lesion or any part of the vascular access has received PTA treatment within the last month;\n6. There are thicker branch veins in the vein opening of the end-to-side anastomosis;\n7. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;\n8. Patients known to be allergic to or intolerant to contrast media;\n9. Patients receiving glucocorticoids or immunosuppressants;\n10. The patient's life expectancy is less than 1 year;\n11. Patients planning kidney transplantation or switching to peritoneal dialysis;\n12. The degree of stenosis in the puncture point area is \\>50%；\n13. Patients with infection or other medical conditions that make the investigator think they are not suitable to participate in this study;\n14. Those who have participated in clinical trials of other drugs or devices but have not completed them.","80 Years",{"count":52,"type":20},140,"INTERVENTIONAL",[55],"NA","This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions.\n\nThis study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.",[58],"Arteriovenous Graft Stenosis",[58,60,61],"Scoring Balloon","Angioplasty","RECRUITING","2025-01-07",{"date":65,"type":33},"2025-01-09",{"date":67,"type":33},"2024-08-13",{"date":69,"type":20},"2026-12",{"name":39,"class":40},7,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100548580","peripheral-scoring-drug-coated-balloon-in-the-treatment-of-hemodialysis-arteriovenous-fistula-stenosis-100548580","NCT06422845","Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis","A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis","SCDB","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years old;\n2. The patient's AVF\u002FAVG is mature and has successfully completed hemodialysis at least once;\n3. The target lesion is located at the AVF\u002FAVG return vein and venous side anastomosis;\n4. Hemodynamically significant AVF\u002FAVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \\\u003C 600 ml\u002Fmin or decreased by 25% compared with the previous follow-up visit, etc.;\n5. The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);\n6. Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;\n7. The patient voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;\n2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;\n3. Calcified lesions that are not expected to be expandable with balloons;\n4. Patients with thrombosis at the access stenosis site;\n5. The target lesion is located at the blood supply artery and arterial anastomosis;\n6. Patients known to be allergic to or intolerant to contrast media and paclitaxel;\n7. The patient's life expectancy is less than 2 years;\n8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;\n9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;\n10. Vascular access infection or systemic active infection;\n11. Those who have participated in unfinished clinical trials of other drugs or devices;\n12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study.",{"count":81,"type":20},328,[55],"This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.",[85],"Arteriovenous Fistula Stenosis",[87,88,89,90],"arteriovenous fistula stenosis","scoring","hemodialysis","drug-coated balloon",{"date":65,"type":33},{"date":93,"type":33},"2024-09-30",{"date":95,"type":20},"2027-07",{"name":39,"class":40},33,""]