[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Endonom Medtech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,88],{"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},"100642263","weflow-endoseal-aorta-vascular-plug-system-for-the-treatment-of-stanford-type-b-aortic-dissection-100642263",false,"NCT07658651","WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection","A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Safety and Efficacy of the WeFlow-EndoSeal™ Aorta Vascular Plug System Combined With TEVAR for the Treatment of Stanford Type B Aortic Dissection","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old.\n2. Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR.\n3. Upon imaging evaluation, The the maximum diameter of the false lumen landing zone where the vascular plug is intended to be deployed shall be in the descending thoracic aorta is ≤ ■■ mm..\n4. Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the iliac artery, infrarenal aorta, or at the level of the renal artery tear.\n5. Patients are able to understand the purpose of the trial, participate in this study voluntarily, has signed the informed consent form personally or via their legal representative, and is willing to complete follow-up in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n1. Presence of persistent malperfusion of visceral arterial branches caused by dissection.\n2. ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■.\n3. Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases).\n4. Acute systemic infection.\n5. History of myocardial infarction, TIA, or stroke within the past 3 months.\n6. NYHA Class IV cardiac dysfunction (see Appendix 1 of the protocol) or LVEF \\\u003C 30%.\n7. Hematologic abnormalities, defined as: leukopenia (WBC \\\u003C 3×10⁹\u002FL), anemia (Hb \\\u003C 90 g\u002FL); coagulopathy, thrombocytopenia (PLT count \\\u003C 50×10⁹\u002FL).\n8. Renal insufficiency with serum creatinine \\> 221 μmol\u002FL (or 2.5 mg\u002FdL) and\u002For end-stage renal disease requiring renal dialysis, as determined by the investigator after comprehensive assessment.\n9. Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5× upper limit of normal; serum total bilirubin (STB) \\> 2× upper limit of normal.\n10. Hypersensitivity to contrast media, materials of the Aorta Vascular Plug, or the delivery system.\n11. Female subjects who are pregnant or breastfeeding.\n12. Concurrent participation in another clinical trial of drugs or devices.\n13. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumor).\n14. Any other medical conditions or abnormalities that, in the investigator's opinion, render the subject ineligible for this study.\n\nIntraoperative Angiography Exclusion Criteria\n\nAfter completion of the stent-graft procedure (including implantation of stents for the proximal and\u002For distal tears as necessary), DSA angiography revealed:\n\n1. Presence of other vascular lesions (e.g., coronary, renal, mesenteric arteries, etc.) requiring intervention, resulting in an impact on the postoperative medical regimen.\n2. Proximal Type I endoleak or Type III endoleak.\n3. Presence of a tear in the descending aorta above the upper margin of the celiac trunk ostium.","ALL","18 Years","80 Years",{"count":20,"type":21},256,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. The main questions it aims to answer are:\n\nDoes WeFlow-EndoSeal™ combined with TEVAR provide superior therapeutic efficacy versus standard TEVAR alone for Stanford type B aortic dissection? Does the combined intervention maintain a comparable safety profile relative to standard TEVAR alone? Researchers will compare the test arm (WeFlow-EndoSeal™ Aorta Vascular Plug System plus TEVAR) with the control arm (standard TEVAR alone), with subjects randomized at a 1:1 ratio, to see if the add-on device enhances treatment outcomes without elevating safety risks.\n\nParticipants will:\n\nBe randomly assigned to either the test arm or the control arm with equal probability, free from subjective influence of investigators or participants Undergo the corresponding standardized endovascular procedure per their group allocation Complete protocol-specified clinical follow-ups and imaging assessments for efficacy and safety evaluation",[27],"Aortic Dissection Type B","RECRUITING","2026-06-14",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2026-06-01",{"date":36,"type":21},"2032-03-01",{"name":38,"class":39},"Hangzhou Endonom Medtech Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100545705","guos-aortic-arch-reconstruction-a-multicenter-prospective-study-of-the-novel-weflow-tribranch-system-genius-study-100545705","NCT06385379","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old;\n2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;\n3. Showing a suitable vascular condition, including:\n\n   * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).\n   * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;\n   * Proximal anchoring zone length ≥ 30 mm;\n   * Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;\n   * Suitable arterial access for endovascular interventional treatment;\n4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him\u002Fherself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.\n5. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.\n\nExclusion Criteria:\n\n1. Experienced systemic infection during past three months;\n2. Neck surgery was performed within 3 months;\n3. Previous endovascular interventional treatment involving the aortic arch was performed;\n4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );\n5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;\n6. Heart transplant;\n7. Suffered Myocardial Infarction or Stroke during past three months;\n8. Class IV heart function (NYHA classification);\n9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;\n10. Hematological abnormality, defined as follows: Leukopenia (WBC \\\u003C 3 ×109\u002FL), acute anemia (Hb \\\u003C 90 g\u002FL), Coagulation disorders, thrombocytopenia (PLT count \\\u003C 50 × 109\u002FL);\n11. Renal insufficiency, creatinine \\> 150 umol\u002FL and\u002For end-stage renal disease requiring renal dialysis;\n12. Pregnant or breastfeeding;\n13. Allergies to contrast agents;\n14. Life expectancy of less than 12 months;\n15. Participating in another drug or device research;\n16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.",{"count":49,"type":21},90,[24],"A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true\u002Fpseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)",[53],"Aortic Arch Aneurysm","2026-04-27",{"date":56,"type":32},"2026-05-01",{"date":58,"type":32},"2024-06-30",{"date":60,"type":21},"2030-12-31",{"name":38,"class":39},20,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100606037","zipper-stent-graft-trial-for-aortic-arch-dissection-100606037","NCT07170332","ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection","Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection","Inclusion Criteria:\n\n* Age: 18-80 years of age.\n\nDiagnosis and Anatomical Suitability:\n\nSubacute or chronic aortic arch dissection requiring intervention, where the proximal end of the stent graft requires anchoring in Zone 0, and meets the following vascular anatomical criteria:\n\nAscending aorta (may include graft segments) ≥ 40 mm in length (measured from the sinotubular junction to the proximal edge of the IA along the centerline).\n\nProximal landing zone diameter ≥ 24 mm and ≤ 47 mm. Proximal landing zone length ≥ 20 mm. Diameters of the IA, LCCA, and LSA ≤ 24 mm and ≥ 6 mm, with lengths ≥ 20 mm. Suitable arterial access for endovascular intervention. Informed Consent: Capable of understanding the study purpose, voluntarily agreeing to participate, and providing written informed consent (by the subject or their legal representative). Willing to comply with follow-up requirements per the protocol.\n\nSurgical Risk Assessment: Deemed high surgical risk (evaluated by at least two independent vascular or cardiac surgeons) or confirmed to have significant contraindications to open surgery.\n\nExclusion Criteria:\n\n* Prior aortic intervention: History of open or endovascular repair of the descending or abdominal aorta.\n\nConcurrent AAA requiring intervention: Coexisting abdominal aortic aneurysm requiring surgical intervention within 30 days.\n\nSpecific aortic pathologies: infectious aortitis, Takayasu arteritis, Marfan syndrome, or other connective tissue disorders.\n\nActive systemic infection: Ongoing systemic infection or high risk of systemic infection.\n\nSevere arch vessel disease: Severe stenosis, calcification, thrombosis, or tortuosity of the IA, LCCA, or LSA.\n\nAcute ischemia: Bowel necrosis or lower limb ischemic necrosis. Pre-existing paraplegia. Post-cardiac transplant status. Recent cardiovascular events: Myocardial infarction or stroke within the past 3 months.\n\nAdvanced heart failure: NYHA Class IV or left ventricular ejection fraction (LVEF) \\\u003C30%.\n\nActive gastrointestinal bleeding: Active peptic ulcer or upper gastrointestinal bleeding within the past 3 months.\n\nHematologic abnormalities: Leukopenia (WBC \\\u003C 3×10⁹\u002FL), Anemia (Hb \\\u003C 90 g\u002FL), Coagulopathy, Thrombocytopenia (platelets \\\u003C 50×10⁹\u002FL).\n\nRenal insufficiency: Serum creatinine \\> 221 μmol\u002FL (2.5 mg\u002FdL) or end-stage renal disease requiring dialysis (investigator discretion).\n\nSevere hepatic dysfunction: ALT\u002FAST \\> 5× upper limit of normal (ULN), Serum total bilirubin (STB) \\> 2× ULN.\n\nHigh-risk intracranial lesions (any of the following):\n\n1. Unruptured aneurysm ≥7 mm (anterior circulation) or ≥5 mm (posterior circulation)\n2. Prior rupture or high-risk morphology (daughter sac, aspect ratio \\>1.6)\n3. Intracranial arterial stenosis ≥50% with poor collateral flow. Contrast allergy. Pregnancy or lactation. Anesthesia\u002Fsurgery contraindications: Severe comorbidities precluding tolerance to anesthesia or surgery.\n\nLife expectancy \\\u003C 12 months. Current participation in other drug or device clinical trials. Other exclusions: Any conditions deemed unsuitable for participation by the investigator.",{"count":71,"type":21},127,[24],"This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system",[75],"Dissection of Aortic Arch",[77,78],"Aortic Arch","Dissection","NOT_YET_RECRUITING","2025-09-11",{"date":82,"type":32},"2025-09-15",{"date":84,"type":21},"2025-09-30",{"date":86,"type":21},"2032-09-30",{"name":38,"class":39},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100588777","guoamps-distal-entry-tear-repair-with-weflow-endopatch-system-gallant-study-100588777","NCT06945809","Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)","Guo&Amp;'s Distal Entry Tear Repair: a Multicenter, Prospective, Superiority, Randomized Controlled Trial of the Novel WeFlow-EndoPatch Aortic Endovascular Patch System","Gallant","Inclusion Criteria:\n\n* Patients aged 18 to 80 years old, no gender limitation;\n* The patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal;\n* The maximum diameter of the descending thoracic aorta is 3.5-5cm；\n* The number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm；\n* With appropriate artery approaches, endovascular treatment can be performed；\n* Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.\n\nExclusion Criteria:\n\n* Rupture or threatened rupture of aortic dissection;\n* Proximal type I internal leakage after aortic repair;\n* New distal SINE;\n* Abdominal aortic dissection aneurysm diameter ≥5 cm;\n* The edge of the tear from the opening of celiac trunk is\\\u003C4 mm;\n* The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.);\n* Acute systemic infection;\n* History of myocardial infarction, TIA or cerebral infarction within the past 3 months;\n* Cardiac function Grade IV (NYHA rating) or LVEF \\< 30%;\n* Hematological abnormalities: leukopenia (WBC \\< 3×10\\^9\u002FL), anemia (Hb \\< 90 g\u002FL); Coagulation dysfunction, thrombocytopenia (PLT count \\< 50×10\\^9\u002FL);\n* Renal insufficiency: serum creatinine \\> 150 umol\u002FL (or 3.0 mg\u002FdL) and\u002For advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;\n* Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;\n* Allergic to contrast agents, anesthetics, patchs, and delivery materials;\n* Pregnant or breastfeeding;\n* Participated in clinical trials of other drugs or devices during the same period;\n* Life expectancy is less than 12 months (such as advanced malignant tumors); Investigator judged that not suitable for interventional treatment.",{"count":97,"type":21},204,[24],"A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)",[101,102],"Aortic Dissection","Distal Entry Tear",[101,104,105],"Distal tear","descending aorta","2025-04-27",{"date":108,"type":32},"2025-04-30",{"date":110,"type":21},"2025-10",{"date":112,"type":21},"2032-10",{"name":38,"class":39},""]