[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FrontAce Scientific Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100557559",false,"NCT06539689","A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries","A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries","SURF","Inclusion Criteria:\n\n* Age 18-85 years old, male or female;\n* The target lesion is located in the superficial femoral artery or the proximal popliteal artery;\n* Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;\n* Estimated life expectancy \\>1 year;\n* Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.\n\nAngiographic Inclusion Criteria:\n\n* Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);\n* Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);\n* After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and\u002For presence of at least one post-PTA dissection (Type A-F) (by visual estimate);\n* Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;\n* Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).\n\nExclusion Criteria:\n\n* Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;\n* Patients with serum creatinine \\>2.5mg\u002Fdl during screening or undergoing long-term hemodialysis or peritoneal dialysis;\n* Severe coagulation disorder;\n* Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);\n* A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);\n* Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;\n* Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;\n* Systemic infection or uncontrolled infection within the target limb;\n* Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;\n* Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;\n* Patients who are planning to have major lower limb amputations on the target side of the lesion;\n* Endovascular or surgical procedures are performed on the target limb within 30 days before or 30 days after surgery;\n* Participating in clinical trials of other medical devices or drugs;\n* The investigator considers the patient is not suitable for participation in the clinical trial.\n\nAngiographic Exclusion Criteria:\n\n* Failure of the guidewire to pass through the lesion；\n* During the procedure, the target lesions had received or were scheduled to receive volume reduction procedures such as cryogenic angioplasty, laser angioplasty, and percutaneous intracavity plaque gyrotomy；\n* The target lesion before stent implantation is thrombotic obliteration, which is not suitable for stent implantation；\n* The target lesions were severely calcified and could not fully predilate; Or grade 4 calcification；\n* Acute vascular occlusion or acute or subacute thrombosis in the target lesion；\n* Stent was implanted into the target vessel before enrollment.","ALL","18 Years","85 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and\u002For dissections in femoral and proximal popliteal arteries.",[27,28,29],"Peripheral Arterial Disease","Stenosis","Dissection",[27,31],"Spot stent","RECRUITING","2024-08-01",{"date":35,"type":36},"2024-08-06","ACTUAL",{"date":38,"type":36},"2024-06-04",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"FrontAce Scientific Co., Ltd","INDUSTRY",12,""]