[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Zylox Medical Device Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100596718","post-market-study-of-zenflex-pro-stent-for-femoropopliteal-artery-lesions-100596718",false,"NCT07049120","Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions","Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions","Inclusion Criteria:\n\n* Clinical Inclusion Criteria:\n\n  1. Aged 18 to 80 years, regardless of gender.\n  2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5.\n  3. Subject (or legal guardian, if applicable) is willing and able to provide consent before to the performance of any study-specific tests or procedures, has signed the consent form and agrees to attend all required follow-up visits.\n* Angiographic Inclusion Criteria:\n\n  1. Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and\u002For proximal popliteal artery (PPA) (i.e., within the P1 segment):\n\n     1. Degree of stenosis ≥70% by visual angiographic assessment.\n     2. Vessel diameter ≥4.0 mm and ≤6.5 mm.\n     3. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).\n     4. Chronic total occlusion with a total lesion length of ≤120 mm.\n  2. Patent popliteal and infrapopliteal arteries, with single-vessel runoff or better, defined as at least one of the three vessels remaining patent (i.e., \\\u003C50% stenosis) down to the ankle or foot.\n\nExclusion Criteria:\n\n* Clinical exclusion criteria:\n\n  1. Pregnant or breastfeeding women, or women\u002Fmen planning to conceive.\n  2. Subjects who have had or are planned for major amputation (at or above the ankle level).\n  3. Subjects known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, contrast agents, etc.\n  4. Subjects with serum creatinine ≥2.5 mg\u002FdL or currently undergoing dialysis.\n  5. Subjects with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≥2 times the upper limit of normal, or platelet count \\\u003C80×10⁹\u002FL).\n  6. Previously stented target lesion\u002Fvessel.\n  7. Target lesion\u002Fvessel previously treated with drug-coated balloon \\\u003C12 months prior to enrollment.\n  8. Subjects with a life expectancy of less than 1 year.\n  9. Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.\n  10. Subjects diagnosed with major clinical diseases or unstable conditions within the past 3 months, such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack or stroke, severe neurological or psychiatric history, severe infections, gastrointestinal bleeding, or active disseminated intravascular coagulation.\n  11. Subjects currently participating in another clinical trial involving drugs or medical devices.\n  12. Subjects whom the investigator considers unsuitable for participation in the clinical trial.\n* Angiographic exclusion criteria:\n\n  1. Presence of aneurysm in the target vessel.\n  2. Heavily calcified lesions (Peripheral Arterial Calcium Scoring System \\[PACSS\\] grades 3-4).\n  3. The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.\n  4. The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.\n  5. Acute ischemia and\u002For acute thrombosis of the SFA\u002FPPA prior to enrollment.","ALL","18 Years","80 Years",{"count":20,"type":21},153,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months.",[27],"Peripheral Arterial Disease","NOT_YET_RECRUITING","2025-06-24",{"date":31,"type":32},"2025-07-03","ACTUAL",{"date":34,"type":21},"2025-06-30",{"date":36,"type":21},"2027-10-31",{"name":38,"class":39},"Zhejiang Zylox Medical Device Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100562595","safety-and-effectiveness-of-the-peripheral-balloon-expandable-covered-stent-system-for-iliac-artery-stenosisocclusion-select-100562595","NCT06605209","Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis\u002FOcclusion. (SELECT)","A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and\u002For Occlusive Lesions in the Common and External Iliac Arteries.","SELECT","Inclusion Criteria:\n\n* Participants aged 18 to 80 years, regardless of sex;\n* Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;\n* Participants with a Rutherford classification of 2 to 4 for the target limb;\n* Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant, or breastfeeding women;\n* Participants who have previously had a vascular graft implanted in the native iliac artery;\n* Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;\n* Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \\< 80×10\\^9\u002FL);\n* Participants with serum creatinine ≥ 221 μmol\u002FL (2.5 mg\u002FdL) or currently undergoing dialysis;\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;\n* Severe anemia (hemoglobin level \\< 60.0 g\u002FL);\n* Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;\n* Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;\n* Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;\n* Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;\n* Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;\n* Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.",{"count":50,"type":21},130,[24],"This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and\u002For occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.",[54],"Peripheral Artery Disease (PAD)",[56,57],"Covered Stent","iliac artery","RECRUITING","2024-11-29",{"date":61,"type":32},"2024-12-04",{"date":63,"type":32},"2024-11-08",{"date":65,"type":21},"2026-12-15",{"name":38,"class":39},""]