[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Acotec Scientific Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,63,87,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100541486","acoart-litos-pcb-below-the-knee-global-trial-100541486",false,"NCT06330493","AcoArt Litos PCB Below-the-knee Global Trial","Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia","Inclusion Criteria:\n\n\\- General Inclusion Criteria\n\n1. Age ≥ 18 years at the time of consent;\n2. Subjects has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Institutional Review Board(IRB)\u002FEthics Commitee(EC) approved consent form;\n3. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses);\n4. Life expectancy \\> 1 year in the Investigator's opinion;\n5. Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5;\n6. In case of Rutherford category 5: Subjects with documented wound score 0-1, infection grade 0-2 and ischemia grade 2-3 according to the wound ischemia foot infection (WIfI) classification;\n7. No other prior surgical or vascular interventions within 2 weeks before and\u002For planned 30 days after the protocol treatment.\n\n   * Angiographic Inclusion Criteria\n8. Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated with available device size matrix;\n9. Total length of target lesion (including significant stenosis 70\\~99% or occlusion) ≤ 190mm;\n10. The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not extend proximal to the P3 segment of the popliteal artery indicated by the tibial plateau or below the tibiotalar joint(arteries of the foot). The treatment(investigational device or PTA, including pre-dilatation) may not extend beyond these indicated regions for more than 1cm;\n11. Presence of documented run-off to the foot(clearly visible at least one of the following run-off vessels; dorsalis pedis or pedal arch or plantar arteries by angiography). The target vessels should give direct or indirect run-off to the foot;\n12. Absence of flow-limiting(≥ 50% stenosis) in-flow lesions confirmed by angiography. Patients with flow-limiting inflow lesions can be included if the lesion(s) have been treated successfully before enrollment, with a maximum residual restenosis of ≤30% per visual assessment. If an inflow lesion must be treated within or proximal to the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy vascular segment between this(treated) lesion and the infrapopliteal target lesion;\n13. Successful pre-dilatation of the(entire) target lesion. Success being documented by angiographic visual estimate of ≤ 50% residual diameter stenosis of the target lesion and no flow limiting dissection(\\\u003C Grade D dissection). Target lesion is not considered non-dilatable by the operator due to concentric, circumferential calcium and target lesion can be treated successfully by balloon angioplasty without the need for bail-out stenting.\n\nExclusion Criteria:\n\n\\- General Exclusion Criteria\n\n1. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre- or post-procedure. A planed amputation including and below the metatarsal level(1 or multiple rays) is accepted.\n2. Recent MI or stroke \\\u003C 30 days prior to the index procedure;\n3. Known or suspected active infection at the time of the index procedure(abnormal white blood cell count, fever, sepsis, or positive blood culture), with the exception of a localized, controlled infection of a lower extremity wound on the target limb(only WIfI infection grade 0-2 allowed);\n4. Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;\n5. Subjects not independently ambulating.\n6. Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation; Subjects with uncomplicated ulcers can be included;\n7. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement;\n8. Subjects with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica on active treatment;\n9. Subjects with impaired renal function defined as eGFR \\\u003C30 ml\u002Fmin or on dialysis;\n10. Patient receiving systemic corticosyeroid therapy(expected dosage exceeding 5 mg of prednisolone or equivalent, per day, during the initial 9 months after procedure);\n11. Known allergies or sensitivities to heparin, aspirin(ASA), other anticoagulant\u002Fanti-platelet therapies which could not be substitued, and\u002For paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure;\n12. Subjects currently enrolled in another investigational device, drug, or biological trial;\n13. Femal subjects who are breast feeding at the time of enrollment;\n14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;\n15. Any severe medical comorbidities(e.g., untreated CAD\u002FCHF, NYHA class IV heart failure, Left Ventricular ejection fraction(LVEF) \\\u003C\u002F= 30%(obtained within 1 month of index procedure), severe COPD, metastatic malignacy, etc.) that would preclude compliance with the study protocol or currently receiving immune-suppressive, chemotherapeutic, or radiation therapy;\n\n    * Angiographic Exclusion Criteria\n16. Occlusions located or extending distal to the ankle joint space;\n17. Untreated (≥50% measured by angiography) inflow lesion or occlusion in the ipsilateral iliac, SFA nad popliteal arteries;\n18. Failure to obtain a ≤30% residual stenosis in pre-existing, hemodynamically significant(≥50% measured by angiography) in flow lesions in the ipsilateral iliac, SFA and popliteal artery. Inflow lesions should be treated per standard of care;\n19. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization);\n20. Previous procedure with drug-coated balloons in the target vessels within 6 months prior to index procedure.\n21. Aneurysm in the target vessel;\n22. Angiographic evidence of thrombus within target limb;\n23. Pre-dilatation resulted in a major(≥ Grade D) flow-limiting dissection(observed on 2 orthogonal views) or residual stenosis \\>50%;\n24. Use of alternative therapy, e.g. atherectomy, scoring balloon, laser, radiation therapy, stents as part of target vessel treatment.","ALL","18 Years",{"count":19,"type":20},288,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)",[26],"Chronic Limb-Threatening Ischemia","RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2025-10-10",{"date":35,"type":20},"2032-10",{"name":37,"class":38},"Acotec Scientific Co., Ltd","INDUSTRY",19,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100430508","acoart-btk-renewa-post-market-clinical-study-100430508","NCT04885985","ACOART BTK RENEW：A Post Market Clinical Study","A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old and ≤75 years old\n* 2\\. Rutherford clinical category classification：3,4 or 5\n* 3\\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.\n* 4\\. Reference vessel diameter is between 2 mm and 4 mm\n* 5\\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.\n\nExclusion Criteria:\n\n* 1\\. Plasma creatinine clearance rate \\\u003C30 mL\u002Fmin\n* 2\\. Acute vessel occlusion or acute thrombosis in target lesion\n* 3\\. Planned amputation on the target limb\n* 4\\. Subjects confined to bed that are completely non-ambulatory.\n* 5\\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.\n* 6\\. Life expectancy \\\u003C 5 year.\n* 7\\. Cumulative length of 100% occluded target lesion(s)\\>150 mm\n* 8\\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm\n* 9\\. History of stroke within 90 days prior to enrollment\n* 10\\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy\n* 11\\. Uncorrectable bleeding diathesis\n* 12\\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery\n* 13\\. Pregnant or breastfeeding female subjects\n* 14\\. Ability to cross a guidewire through target lesion\n* 15\\. Patients who have participated in clinical trials of other medical devices or drugs during the same period","75 Years",{"count":49,"type":20},107,[23],"The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.",[53],"Peripheral Artery Disease","2024-07-30",{"date":56,"type":31},"2024-08-01",{"date":58,"type":31},"2021-12-31",{"date":60,"type":20},"2027-04-01",{"name":37,"class":38},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":62},"100410696","acoart-intracranial-isr-pilotintracranial-dcb-in-the-treatment-of-intracranial-in-stent-restenosis-100410696","NCT04627870","ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis","A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis","Inclusion Criteria:\n\n* 18 to 80 years of age\n* Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as \\>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \\>20% absolute luminal loss\n* presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor\n* asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and\u002For by an American Society of Interventional and Therapeutic Neuroradiology\u002FSociety of Interventional Radiology (ASITN\u002FSIR) Collateral Flow Grading System score \\\u003C3 on DSA.\n* the diameter of target vessel is 2.0-4.5mm\n* there is only one intracranial ISR lesion per subject\n* baseline mRS score ≤2\n* Voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with stroke within 2 weeks before procedure;\n* any history of brain parenchyma or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days.\n* Those who have received thrombolysis within 24 hours before procedure;\n* Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline)\n* patients with thrombus in target vessels.\n* in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.\n* Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.\n* patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.\n* Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.\n* Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;\n* patients with myocardial infarction within 6 weeks before procedure.\n* those who cannot tolerate general anesthesia due to insufficiency of heart, lung and other important organs.\n* patients with known severe hepatic and renal dysfunction.\n* patients with hemoglobin \\\u003C 100g \u002F L, platelet count \\\u003C 100,000 \u002F mm3, INR \\> 1.5or with uncorrectable factors leading to bleeding.\n* patients who cannot receive dual antiplatelet therapy due to existing diseases or who are tested to be tolerant to dual antiplatelet therapy.\n* Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs\n* current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure \\> 180mmHg or diastolic blood pressure \\> 110mmHg).\n* Life expectancy \\\u003C 1 year.\n* pregnant or lactating women.\n* patients who are unable to complete follow-up due to cognitive, emotional disorders or mental illness.\n* Patients who are participating in other drug\u002Fdevice clinical trials and have not completed all follow-ups required by the programme;\n* According to the judgement of the investigator, other situations that are not suitable for enrollment","80 Years",{"count":72,"type":20},20,[23],"The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.",[76,77],"Intracranial Atherosclerosis","Stroke",[76,79,80],"In-stent restenosis","drug coated balloon",{"date":56,"type":31},{"date":83,"type":31},"2021-05-26",{"date":85,"type":20},"2025-12-30",{"name":37,"class":38},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100392697","acotec-dcb-post-market-clinical-follow-up-100392697","NCT04393389","Acotec DCB Post Market Clinical Follow-up","All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment","FLOWER","Inclusion Criteria:\n\n* 1\\. Patient is ≥ 18 years old at the time of consent.\n* 2\\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and\u002For infra-popliteal arteries suitable for angioplasty per operator visual assessment.\n* 3\\. Lesion(s) can be treated with available AcoArt Orchid (0.035\"), AcoArt Tulip (0.018\") and AcoArt Litos (0.014\") DCB device per current IFU.\n* 4\\. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments.\n* 5\\. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.\n* 6\\. Inflow lesion treated prior to target lesion treatment\n\nExclusion Criteria:\n\n* 1\\. Rutherford Classification Category 0, 1\n* 2\\. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints\n* 3\\. Inability to tolerate required antithrombotic or antiplatelet therapies.\n* 4\\. Non-dilatable severely calcified lesion.\n* 5\\. Known hypersensitivity\u002Fallergy to components of the investigational device\n* 6\\. Un-treated acute or subacute thrombus in the target lesion.\n* 7\\. Life expectancy \\\u003C 1 year.\n* 8\\. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.\n* 9\\. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.\n* 10\\. Myocardial infarction or stroke within 30 days prior to index procedure.",{"count":96,"type":20},3000,"OBSERVATIONAL","All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6",[53],{"date":56,"type":31},{"date":102,"type":31},"2020-06-04",{"date":104,"type":20},"2027-03-01",{"name":37,"class":38},7,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":62},"100531882","acoart-avf-renew-a-post-market-clinical-study-100531882","NCT06205576","ACOART AVF RENEW: A Post Market Clinical Study","A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)","Inclusion Criteria:\n\n* Patient is ≥18 and ≤85 years of age\n* The target AV fistula has undergone successful dialysis for at least 1 time\n* Patient has a de novo and\u002For non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）\n* Patient has a de novo and\u002For non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：\n\n  * The physical examination was abnormal\n  * Significant increase in dynamic venous pressure\n  * Blood flow decreased significantly\n* Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length\n* Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:\n\n  * Residual stenosis of ≤ 30% AND\n  * Absence of a flow limiting dissection (Grade ≥C) or perforation\n* Patient provides written informed consent prior to enrollment in the study\n\nExclusion Criteria:\n\n* Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children\n* Dialysis access is located in the lower extremity\n* More than one lesion\n* Patient with hemodynamically significant central venous stenoses\n* Patient has presence of a stent located in the target AV access circuit\n* Patient has undergone prior intervention of access site within 30 days of index procedure\n* Patient with target AVF or access circuit which previously had or currently has a plan to surgery\n* Patient who cannot receive recommended antiplatelet and\u002For anticoagulant therapy\n* Patients undergoing immunotherapy or suspected\u002Fconfirmed vasculitis\n* Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type\n* Patient has an infected AV access or systemic infection\n* Patient has a life expectancy of \\\u003C24 months\n* Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis\n* Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him\u002Fher to be non-compliant with the protocol or confound the data interpretation\n* Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study","85 Years",{"count":116,"type":20},164,[23],"The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).",[120],"Stenosis of Native Hemodialysis Arteriovenous Fistulas","2024-01-04",{"date":123,"type":31},"2024-01-16",{"date":125,"type":31},"2023-02-20",{"date":127,"type":20},"2027-06",{"name":37,"class":38},""]