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Dr.","01186-21-38804518","22265","vascular_doc@qq.com",[42,57,69,81,93,106,118,129,141,153,165,176],{"facility":43,"status":44,"city":45,"state":46,"zip":25,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beijing Friendship Hospital, Capital Medical University","NOT_YET_RECRUITING","Beijing","Beijing Municipality","China",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":25,"phoneExt":25,"email":25},"Hai Feng",{"facility":58,"status":44,"city":59,"state":60,"zip":25,"country":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality",{"type":49,"coordinates":62},[63,64],106.55771,29.56026,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":25,"phoneExt":25,"email":25},"Yu Zhao",{"facility":70,"status":44,"city":71,"state":72,"zip":25,"country":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"The Second 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Zhang",{"facility":166,"status":44,"city":167,"state":25,"zip":25,"country":47,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Hospital of Chengdu University of TCM","Chengdu",{"type":49,"coordinates":169},[170,171],104.06667,30.66667,{"lat":171,"lon":170},[174],{"name":175,"role":32,"phone":25,"phoneExt":25,"email":25},"Chunshui He",{"facility":177,"status":95,"city":131,"state":25,"zip":25,"country":47,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},"Shanghai East Hospital",{"type":49,"coordinates":179},[135,136],{"lat":136,"lon":135},[182],{"name":183,"role":32,"phone":25,"phoneExt":25,"email":25},"Xiang Wang",{"type":185,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":197,"type":198},240,"ESTIMATED","INTERVENTIONAL",[201],"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.",[204,205,206],"Peripheral Arterial Disease","Stenosis","Dissection",[204,208],"Spot stent","2024-08-01",{"date":211,"type":212},"2024-08-06","ACTUAL",{"date":214,"type":212},"2024-06-04",{"date":216,"type":198},"2026-12-31",{"name":5,"class":6},12]