[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-with-peripheral-artery-calcified-lesions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-with-peripheral-artery-calcified-lesions":26},{"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":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":34,"leadSponsor":36,"locationsCount":4},"100657378","a-prospective-multicenter-randomized-parallel-controlled-superiority-clinical-trial-evaluating-the-safety-and-efficacy-of-single-use-peripheral-intravascular-shock-wave-catheters-combined-with-intravascular-shock-wave-therapy-devices-for-peripheral-artery-calcified-lesions-100657378",false,"NCT07839143","A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.","Inclusion Criteria:\n\nGeneral selection criteria\n\n1. Age 18 to 80 years old, regardless of gender;\n2. Rutherford grade is 2 to 5\n3. As judged by the investigator, peripheral endovascular treatment is required;\n4. The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;\n5. The subject is willing comply with all assessment requirements in the trial;\n\nInclusion criteria for angiography:\n\n1\\) Target lesions are vascular calcified lesions of grade Ⅲ to Ⅳ according to PARC classification: 2 Target lesions are located in native femoral artery and\u002For popliteal artery; 3) Total of target lesion ≤260mm; if it contains occlusive lesion, length of occlusive segment ≤100mm and total length of target lesion ≤20mm; 4) Target lesions have not undergone any surgical interventions including endovascular therapy and open surgery before, and the stenosis degree target lesion is ≥70% (visual assessment); 5) Reference vessel diameter of target is between 2.5mm and 8.0mm; 6) At least one distal outflow tract of target lesion is (vascular stenosis degree ≤50% by visual assessment), with blood flow reaching foot (not dependent on collateral circulation); or the patient has successfully undergone treatment for target lesion before (i.e., residual stenosis degree ≤30% by visual assessment after treatment, without serious complications); 7) The ipsilateral inflow tract of target lesion is patent (vascular stenosis degree ≤50% by visual assessment), or the patient has successfully undergone treatment for lesion before (i.e., residual stenosis degree ≤30% by visual assessment treatment, without serious complications);\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. History of amputation of target limb or planned major amputation (above the ankle\n2. INR \\> 3 or platelet count \\\u003C 60×10\\^9\u002FL;\n3. Patients with known renal insufficiency (ser creatinine \\>2.5 mg\u002FdL or 220 μmol\u002FL) or renal failure requiring long-term dialysis;\n4. Patients with known contraindications to antiplatelet andagulant therapy;\n5. Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;\n6. Patients who have receivedbolytic therapy in the target vessel within 14 days prior to signing informed consent; ) Patients who have experienced myocardial infarction within 60 days prior to signing informed consent;\n\n8\\) Patients who have experienced stroke within 60 days prior to signing informed consent; 9) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy; 10) Patients participating in other medical device or drug clinical trials; 11) Other reasons considered by the investigator as inappropriate for participation in the trial.\n\nAngiography exclusion criteria:\n\n1. The target vessel has evidence of aneurysm or acute\u002Fchronic thrombosis;\n2. The vessel is highly tortuous (the visual arc is greater than 30°);\n3. The guidewire cannot pass through the target lesion; 4 There is in-stent restenosis in the target lesion area;\n\n5\\) Before treating the lesion with research devices, ablative devices such as cutting balloons, scoring balloons, compliant balloons, mammillary balloons, pronged balloons, plaque excision devices, excimer laser systems, and peripheral throm aspiration catheters need to be used.","ALL","18 Years","80 Years",{"count":19,"type":20},158,"ESTIMATED","INTERVENTIONAL",[23],"NA","This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.",[26],"Patients With Peripheral Artery Calcified Lesions","NOT_YET_RECRUITING","2026-09-18",{"date":30,"type":31},"2026-09-24","ACTUAL",{"date":33,"type":20},"2026-09",{"date":35,"type":20},"2027-12-15",{"name":37,"class":38},"Shanghai Bluesail Boyuan Medical Technology Co., Ltd.","INDUSTRY"]