[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biotyx Medical (Shenzhen) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100615245","a-first-in-man-clinical-trial-to-evaluate-the-safety-and-feasibility-of-ics-elpis-in-patients-with-iliac-artery-stenosis-or-occlusion-lesions-100615245",false,"NCT07290101","A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions","A Prospective, Single-Center, First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in Patients With Iliac Artery Stenosis or Occlusion Lesions","Inclusion Criteria:\n\nGeneral inclusion criteria\n\n1. Patients with stenosis or occlusion of the common iliac artery and\u002For external iliac artery caused by atherosclerosis.\n2. Age between 18 - 85 years old. Male or non-pregnant female.\n3. Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4).\n4. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements.\n\nAngiographic Inclusion Criteria\n\n1. Patients with evidence of unilateral or bilateral de novo or restenosis (non-stent treatment) lesion(s) in the common iliac artery and\u002For external iliac artery, with the stenosis degree of the target lesion being≥50% (including occlusion).\n2. The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized balloon.\n3. The target lesion(s) with reference vessel diameter between 4.0 mm and 12.0 mm, and total length of unilateral lesion(s) ≤ 100 mm (tandem lesions are allowed).\n4. Up to two ipsilateral target lesions or bilateral lesions are allowed (one target lesion per limb, with the length adhering to the unilateral criterion). Up to two stents are allowed for stent overlap per side (i.e., a maximum of two stents can be implanted per side).\n5. Patients with angiographic evidence of patent outflow vessels in the target limb, including: a healthy common femoral artery (\\\u003C50% stenosis); at least one of the deep femoral artery or superficial femoral artery is patent (\\\u003C50% stenosis); a healthy popliteal artery (\\\u003C50% stenosis); and at least one patent infrapopliteal vessel connected (\\\u003C50% stenosis).\n6. For stenotic or occlusive target lesion(s) located at the ostium of the common iliac artery without a residual stump, intervention can be achieved through kissing stent technique.\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n1. Patients with previously stented target lesion.\n2. Patients who have undergone lower extremity arterial intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure.\n3. Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.\n4. Patients who were expected to undergo amputation of the target limb before the index procedure.\n5. Patients with an aneurysm, perforation and\u002For dissection of the target iliac artery before the index procedure.\n6. Patients who have undergone coronary artery intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure (including the index procedure).\n7. Patients with acute myocardial infarction or angina pectoris within 30 days before the index procedure.\n8. Patients with a stroke within 3 months before the index procedure, or a stroke more than 3 months before the index procedure accompanied by severe paralysis and aphasia sequelae.\n9. Patients with known intolerance to antiplatelet, anticoagulant, or thrombolytic medications.\n10. Patients with known diseases (not related to the trial) that require indefinite or lifelong anticoagulation therapy.\n11. Patients with known allergies to aspirin, heparin, clopidogrel, contrast agent, poly(lactide), iron and its degradation products.\n12. Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.\n13. Patients with coagulation insufficiency (platelet count \\\u003C 80\\*109\u002FL), systemic coagulation disorders or hypercoagulable tendencies.\n14. Patients with severe hepatic or renal insufficiency (serum creatinine \\>2 times the upper limit of normal or on renal dialysis; ALT or AST \\> 5 times the upper limit of normal).\n15. Patients with a life expectancy of less than two years.\n16. Patient currently participating in another clinical trial, and have not yet completed that trial.\n17. Patients who are not suitable for participating the trial as per investigator judgement.\n\nAngiographic Exclusion Criteria\n\n1. Patients with angiographic evidence of thrombus within or adjacent to the target lesion(s).\n2. Patients with a history of ipsilateral iliac artery stenting, where the distance between the previously implanted stent and the current target lesion is ≤ 5 mm.\n3. Patients with coexisting ipsilateral iliac aneurysms or abdominal aortic aneurysms.\n4. Patients in whom the internal iliac artery is patent, but implanting the stent in the target lesion will block the blood flow from entering the internal iliac artery.\n5. Patients requiring placement of a study device within 2 cm proximal to the inguinal ligament.\n6. Patients with severe calcification of the target lesion which makes it impossible for the pre-dilation balloon to reach its nominal diameter.","ALL","18 Years","85 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled.",[27,28],"Iliac Artery Stenosis","Iliac Artery Occlusion",[30,31,32],"iliac artery occlusion","Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System","iliac artery stenosis","NOT_YET_RECRUITING","2025-12-04",{"date":36,"type":37},"2025-12-18","ACTUAL",{"date":39,"type":21},"2025-12-08",{"date":41,"type":21},"2028-03-01",{"name":43,"class":44},"Biotyx Medical (Shenzhen) Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100513893","ibs-titan-sirolimus-eluting-iron-bioresorbable-peripheral-scaffold-system-clinical-trial-100513893","NCT05971394","IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial","A Prospective, Multicentre, Single Arm Clinical Trial to Assess the Safety and Effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in Treating Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease","Inclusion Criteria:\n\n• General criteria\n\n1. Subject between 18 and 85 years old.\n2. Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.\n3. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.\n4. Subject requires primary treatment of de novo infrapopliteal lesions.\n\n   • Angiographic criteria\n5. Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.\n6. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.\n7. The target lesion must be located in the proximal 2\u002F3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.\n8. Only two infrapopliteal vessels are allowed to be treated at the same time.\n9. A maximum of two stents can be deployed at one target vessel.\n10. There must be at least one unimpaired artery (\\\u003C 30% stenosis) to the ankle.\n\nExclusion Criteria:\n\n• General criteria：\n\n1. Severe renal insufficiency, hepatic dysfunction (Cr \\> 2 times normal limit or renal dialysis, ALT or AST \\> 5 times normal limit).\n2. Major amputation before index procedure or plan for major amputation.\n3. Any coagulation disorder.\n4. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.\n5. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.\n6. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.\n7. Thromboangiitis obliterans (Buerger's disease).\n8. Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.\n9. Any surgery in target vessel before index procedure.\n10. Volume reduction operation in target vessel before inclusion.\n11. Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.\n12. Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.\n13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.\n14. Women of child-bearing potential not using an effective contraception; pregnant or lactating women.\n15. Subject is not suitable to participate in the trial as per investigators discretion.\n16. Life expectancy ≤ 12 months as per investigators judgement.\n\n    • Angiographic criteria\n17. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis \\>30% with or without intervention.\n18. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has \\> 150 mm stenosis or occlusion before treatment.\n19. Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel.\n20. In-stent restenosis in any lower extremity artery.\n21. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.\n22. Guide wire cannot pass target lesion.\n23. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.\n24. Aneurysm of lower extremity artery in the ipsilateral leg.",{"count":54,"type":21},100,[24],"The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.",[58,59],"Infrapopliteal Lesions","Critical Limb Ischemia",[61,62,63],"BTK","below-the-knee","Infrapopliteal lesions","RECRUITING","2023-07-31",{"date":67,"type":37},"2023-08-02",{"date":69,"type":37},"2023-07-17",{"date":71,"type":21},"2026-07",{"name":43,"class":44},""]