[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MDCECRO LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100602335","post-market-registry-study-on-the-safety-and-efficacy-of-zenflex-pro-peripheral-drug-eluting-stent-system-for-femoropopliteal-artery-lesions-100602335",false,"NCT07122167","Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions","Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesion","Inclusion Criteria:\n\n* (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (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\nAngiographic Inclusion Criteria:\n\nEligible subjects must meet all of the following angiographic criteria:\n\n1. 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.\n2. 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\nSubjects will be excluded from the study if any of the following conditions are present:\n\n1. Pregnant or breastfeeding women, or women\u002Fmen planning to conceive.\n2. Subjects who have had or are planned for major amputation (at or above the ankle level).\n3. 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.\n4. Subjects with serum creatinine ≥2.5 mg\u002FdL or currently undergoing dialysis.\n5. 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).\n6. Previously stented target lesion\u002Fvessel.\n7. Target lesion\u002Fvessel previously treated with drug-coated balloon \\\u003C12 months prior to enrollment.\n8. Subjects with a life expectancy of less than 1 year.\n9. Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.\n10. 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.\n11. Subjects currently participating in another clinical trial involving drugs or medical devices.\n12. Subjects whom the investigator considers unsuitable for participation in the clinical trial.\n\nAngiographic exclusion criteria:\n\n1. Presence of aneurysm in the target vessel.\n2. Heavily calcified lesions (Peripheral Arterial Calcium Scoring System \\[PACSS\\] grades 3-4).\n3. The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.\n4. The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.\n5. 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",[29],"peripheral arterial disease","RECRUITING","2025-09-05",{"date":33,"type":34},"2025-09-12","ACTUAL",{"date":36,"type":34},"2025-06-02",{"date":38,"type":21},"2027-02-01",{"name":40,"class":41},"MDCECRO LLC","NETWORK",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":5},"100559238","the-gastric-bypass-stent-system-as-a-treatment-for-hepatic-fibrosis-in-obese-patients-in-european-region-100559238","NCT06561529","The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region","A Prospective, Open-label, Single-arm Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region","Subjects who meet all of the following criteria are eligible for this clinical investigation:\n\n1. Age 18-65 years.\n2. BMI ≥ 30 kg\u002Fm².\n3. Medical history suggests suspected or confirmed NASH fibrosis. Meeting any of the following criteria indicates NASH liver fibrosis:\n\n   * Historical biochemical tests for fibrosis: PRO-C3 \\>14 ng\u002FmL or ELF ≥9\n   * Fibroscan, transient elastography ≥8.5 kPa, controlled attenuation parameter ≥280 dB\u002Fm\n   * Based on existing pathology review, liver biopsy within \\\u003C2 years before the expected randomization shows stage 1B, 2, or 3 fibrosis NASH, with no significant weight change \\>5% or medications likely affecting NAS or fibrosis stage.\n4. Liver biopsy confirming NASH within 6 months before the randomization date, with liver biopsy fibrosis stage 1-3, NAS ≥3, and at least a score of 1 for the following NAS components:\n\n   * Steatosis (0-3 points)\n   * Ballooning (0-2 points)\n   * Lobular inflammation (0-3 points)\n5. Patients who have not achieved effective results after three months of lifestyle modifications and non-invasive treatments (non-diabetic patients have not achieved a weight loss of 5%, diabetic patients have not achieved a weight loss of 3%).\n6. Able and willing to provide informed consent for participation in the clinical investigation and comply with all study procedures and assessments.\n\nSubjects who meet any of the following criteria are not eligible for this clinical investigation:\n\n1. Patients with liver cirrhosis\n2. Patients with secondary obesity; a medical condition that has caused weight gain such as endocrine disorders and hypothalamic disorders.\n3. Chronic, daily use of systemic anti-inflammatory or corticosteroid medications (e.g., ibuprofen, prednisolone) for more than 1 week (not including low-dose aspirin for cardiac prophylaxis or inhaled corticosteroids).\n4. Patients with less than one-year continuous treatment before baseline with hypoglycemic drugs with known weight loss effects (e.g., GLP-1 agonists, SGLT-2 inhibitors, DDP-4 inhibitors).\n5. Patients diagnosed with type 1 diabetes.\n6. Patients with the function of islet β cell basically lost, C-peptide ≤ 1\u002F2 of the normal low limit, or low and flat C-peptide release curve under glucose load.\n7. Patients with significant iron deficiency or iron deficiency anemia upon the Investigator's discretion.\n8. Patients with coagulation dysfunction and chronic, daily use of systemic anti-inflammatory or anti-coagulation medication in the past month (not including low-dose aspirin).\n9. Patients with severe liver and kidney dysfunction, and a serum creatinine concentration ≥ 180 μmol\u002FL.\n10. Patients with Class III heart function of New York Heart Association Functional Classification (NYHA) or higher upon the Investigators evaluation.\n11. Patients who have undergone Endoscopic Retrograde Cholangiopancreatography (ERCP) or have a history of cholecystitis or liver abscess, as assessed by medical history and abdominal ultrasound.\n12. Patients with a duodenal ulcer, gastric ulcer, or previous and existing pancreatitis, as assessed by abdominal ultrasound, gastroscopy (prior to the procedure at Visit 3), and medical history.\n13. Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms as assessed by abdominal ultrasound and medical history.\n14. Patients with on-going thyroid dysfunction, not stabilized despite appropriate treatment.\n15. Patients with hemorrhage or potential hemorrhage in the digestive tract.\n16. Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract, as assessed by gastroscopy (prior to the procedure at Visit 3), abdominal digital gastrointestinal radiography, and medical history.\n17. Patients with a history of bowel obstruction or related diseases in the past year.\n18. Patients with a history of systemic lupus erythematosus or scleroderma.\n19. Patients with severe infections that are not controlled.\n20. Patients with poor general condition and having endoscopic contraindications (as evaluated by the Investigator).\n21. Pregnant women or planning to become pregnant.\n22. Patients with an alcohol dependence or substance abuse.\n23. Patients with unstable psychiatric disorders.\n24. Patients who are enrolled in another investigational study and have not completed the required follow-up period.\n25. Patients with an allergy to any of the components of the investigational device.\n26. Patients with any other conditions evaluated by the Investigators as unsuitable for participating in the clinical investigation.\n27. Patients who are positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus as determined by antibodies, deoxy\u002Fribonucleic acid (DNA\u002FRNA), or antigens.\n\nNote: Anti-HCV positive, but HCV-RNA negative HCV patients can be included, based on investigator's judgement, if it's not the primary reason for the fibrosis. Anti-HBc positive, but HBs-Ag negative patients can be included, based on investigator's judgement.","65 Years",{"count":52,"type":21},10,[24],"The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.",[56,57],"Fibrosis","Liver","2025-05-06",{"date":60,"type":34},"2025-05-08",{"date":62,"type":34},"2024-06-13",{"date":64,"type":21},"2025-12",{"name":40,"class":41},""]