[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-dissection-type-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-dissection-type-b":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,68,95],{"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":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100608187","teavr-with-false-lumen-embolization-for-aortic-dissection-100608187","NCT07198295","TEAVR With False Lumen Embolization for Aortic Dissection","Thoracic Endovascular Repair With False Lumen Embolization for Aortic Dissection: A Multicenter, Prospective, Observational Study","Inclusion Criteria\n\nPatients must meet all of the following conditions to be enrolled:\n\n1. Diagnosed with acute or subacute (symptom onset ≤30 days) Stanford type B aortic dissection.\n2. Present with typical clinical symptoms and imaging-confirmed aortic dissection.\n3. Dissection extends distally to involve the infrarenal abdominal aorta.\n4. Scheduled to undergo elective TEVAR combined with false lumen embolization.\n\nExclusion Criteria\n\nPatients will be excluded if they meet any of the following conditions:\n\n1. Requiring emergency surgery due to rupture, impending rupture, or severe malperfusion.\n2. Complicated type B dissection (e.g., visceral\u002Flimb ischemia, refractory pain, or hemodynamic instability).\n3. Suspected traumatic or infectious etiology of the dissection.\n4. Previous history of aortic surgery or endovascular repair.\n5. Use of alternative techniques during the procedure (e.g., PETTICOAT, long-segment coverage).\n6. Uncontrolled systemic diseases (e.g., severe cardiac\u002Fpulmonary\u002Fhepatic dysfunction, advanced malignancy, cachexia, or uncorrectable coagulation disorders).\n7. Myocardial infarction or stroke within the past 6 months.\n8. Age \\\u003C18 years or \\>80 years.\n9. Patient refusal to participate in the study.",{"count":49,"type":21},72,"OBSERVATIONAL","This multicenter, prospective, observational study aims to evaluate the efficacy and safety of thoracic endovascular aortic repair (TEVAR) combined with false lumen embolization using vascular plugs in patients with acute type B aortic dissection. Despite TEVAR being a standard treatment for type B dissection, long-term outcomes remain suboptimal due to persistent false lumen perfusion through distal re-entry tears, leading to aortic expansion and high reintervention rates. This study addresses the clinical need for a more definitive treatment strategy that promotes complete false lumen thrombosis and aortic remodeling.\n\nThe study plans to enroll 72 subjects across multiple centers in China, with each participant followed for 12 months. Key inclusion criteria comprise patients with acute or subacute (≤30 days from onset) type B aortic dissection exhibiting typical symptoms and extending to the infrarenal aorta, who are scheduled for the combined procedure. Exclusion criteria included those requiring emergency surgery, complicated dissections with malperfusion or rupture, trauma-related or infectious etiologies, prior aortic surgery, uncontrolled systemic diseases, recent myocardial infarction or stroke, and patients outside the 18-80 age range or refusing participation.\n\nThe primary efficacy endpoint is the complete thrombosis rate of the false lumen in the thoracic aorta at 12 months postoperatively, while the primary safety endpoint is the incidence of major adverse events (MAEs) at the same time point. MAEs are defined as a composite of all-cause mortality, myocardial infarction, respiratory failure requiring prolonged ventilation or reintubation, renal deterioration (\\>50% reduction in eGFR or new dialysis), bowel ischemia requiring surgery or refractory to medical therapy, major stroke, and grade 3 paraplegia. Secondary endpoints include thrombosis rates at 1 and 6 months in the thoracic aorta, patency and thrombosis status at the celiac trunk and infrarenal aortic levels at 1, 6, and 12 months, incidence of MAEs at earlier timepoints, and rates of endoleaks and reinterventions.\n\nAll subjects will receive a standardized treatment protocol involving TEVAR with stent-graft placement to seal the proximal entry tear, followed by selective catheterization of the false lumen and deployment of 1-3 vascular plugs at predetermined locations: one parallel to the distal edge of the thoracic stent-graft, one at the level of the celiac trunk, and one at the distal re-entry tear in the infrarenal aorta. Follow-up assessments are scheduled at 1, 6, and 12 months post-procedure, including clinical evaluation and thoracoabdominal CTA imaging to assess aortic remodeling and complication status.\n\nThis investigation represents the first prospective multicenter effort to evaluate the combined TEVAR and false lumen embolization strategy. By addressing the fundamental limitation of conventional TEVAR-incomplete false lumen exclusion-this study may establish a new standard for achieving complete aortic remodeling in type B dissection. The results are anticipated to provide robust evidence for guiding clinical practice and potentially influencing future treatment guidelines in aortic disease management.",[27],[54,55,56],"Type B aortic dissection","Thoracic endovascular repair","false lumen embolization","NOT_YET_RECRUITING","2025-09-22",{"date":60,"type":32},"2025-09-30",{"date":62,"type":21},"2025-10-01",{"date":64,"type":21},"2029-12-31",{"name":66,"class":67},"First Affiliated Hospital of Zhejiang University","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":40},"100584698","safety-and-efficacy-of-tevar-combined-with-long-bare-metal-stents-in-the-intervention-of-atbad-100584698","NCT06892730","Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD","Safety and Efficacy of TEVAR Combined With Long Bare-metal Stents in the Intervention of ATBAD: a Prospective and Cohort Study","SAFE-COVER","Inclusion Criteria:\n\n* ≧18 years old, ≦80 years old;\n* Acute phase with a course of disease ≦14 days;\n* CTA confirmed diagnosis of active dissection type B in accordance with the Stanford classification in the ESC guidelines, and requiring TEVAR surgery;\n* For patients with acute non-type A and non-type B aortic dissection involving the left subclavian artery: current technologies (such as fenestration, single branch, chimney, etc.) can be used to solve the reconstruction of the left subclavian artery;\n* The distal end of the dissection exceeds the renal artery plane;\n* Signed informed consent (emergency waiver applicable), with primary intervention using CTAG devices. Adjunctive procedures may include LSA revascularization, percutaneous fenestration, aortic\u002Fperipheral stenting, surgical fenestration, or bypass grafting.\n* Medical record completeness \\>90% with mandatory CTA data;\n* Protocol compliance including follow-up adherence\n\nExclusion Criteria:\n\n* Dissection termination above renal arteries;\n* Major aortic surgery within 30 days prior (except LSA revascularization);\n* Iliofemoral stenosis\u002Fangulation precluding endovascular access;\n* Non-diagnostic CTA image quality;\n* Indeterminate symptom onset time;\n* Traumatic TBAD, intramural hematoma, or penetrating aortic ulcer;\n* Complete thoracic aortic thrombosis pre-TEVAR;\n* Re-intervention within 12 months post-TEVAR for non-aortic indications;\n* Renal failure: Baseline serum creatinine \\>2.5 mg\u002FdL (high-risk for contrast nephropathy);\n* Known device material hypersensitivity;\n* Systemic infection increasing endograft infection risk;\n* Evidence of aortic infection;\n* Connective tissue disorders (e.g., Marfan syndrome);\n* Bowel necrosis from visceral ischemia;\n* Participation in other device\u002Fdrug trials within 1 year;\n* Moribund status: ASA class 5 with \\\u003C24h life expectancy;\n* Refractory shock (SBP \\\u003C90 mmHg);\n* Pregnancy or lactation;\n* Active substance abuse.",{"count":77,"type":21},200,[24],"The primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acute complicated type B aortic dissection (ATBAD).\n\nAdditionally, to prevent postoperative true lumen hypoperfusion in residual thoracoabdominal aortic dissection (visceral zone, infrarenal aorta, and iliac arteries) and persistent ischemic manifestations in visceral and lower extremity arteries post-endovascular repair, extended bare-metal stents are deployed to maintain adequate distal true lumen patency. This strategy ensures perfusion to visceral branches and lower limbs while preparing for future complete endovascular aortic repair.",[27],[82,83,84,85],"ATBAD","TEVAR","Extension","Long bare metal scaffolding devices","2025-03-21",{"date":88,"type":32},"2025-03-25",{"date":90,"type":21},"2025-03-31",{"date":92,"type":21},"2027-03-31",{"name":94,"class":67},"Yan'an Affiliated Hospital of Kunming Medical University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":40},"100506424","cratos---evaluation-of-cratos-branch-stent-graft-system-in-treatment-of-descending-aorta-lesions-100506424","NCT05874206","CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions","Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions","Inclusion Criteria:\n\n1. Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2\n2. Age ≥18 years at time of informed consent signature\n3. Informed Consent Form (ICF) is signed by Subject or legal representative\n4. Must have appropriate proximal aortic landing zone, defined as:\n\n   * Landing zone inner diameters between 23-41 mm\n   * The length of landing zone ≥15mm\n   * Landing without heavily calcified or heavily thrombosed\n   * Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.\n   * For patients with prior replacement of the ascending aorta and\u002For aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.\n5. Must have appropriate LSA landing zone, defined as:\n\n   * Inner diameters of LSA 5-14 mm\n   * Minimum length of Left subclavian artery is 25 mm\n   * Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.\n6. Must have appropriate distal aortic landing zone, defined as:\n\n   * Aortic inner diameters between 18-44 mm\n   * Landing zone cannot be heavily calcified, or heavily thrombosed.\n   * For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery\n   * Landing zone in native aorta\n\nExclusion Criteria:\n\n1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair\n2. Previous endovascular repair of the ascending aorta\n3. Infected aorta, active systemic infection\n4. Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .\n5. Life expectancy \\\u003C1 years\n6. Myocardial infarction within 6 weeks prior to treatment\n7. Stroke within 6 weeks prior to treatment.\n8. Pregnant or breastfeeding female\n9. Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.\n10. Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome\n11. Participation in another drug or medical device study within one year of study enrolment\n12. Known history of drug abuse within one year of treatment\n13. Tortuous or stenotic iliac and\u002For femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access\n14. Planned coverage of celiac artery\n15. Allergic to contrast agents, anaesthetics and delivery materials\n16. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin\n17. Patient with a history of a hypercoagulability disorder and\u002For is currently in a hypercoagulability state\n18. Persistent refractory shock (systolic blood pressure \\\u003C90 mm Hg)\n19. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C30 (ml\u002Fmin\u002F1.73 m2) or currently requiring dialysis\n20. Contraindications to antiplatelet drugs and anticoagulants\n21. Investigator judged that not suitable for interventional treatment.",true,{"count":104,"type":21},130,[24],"The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\\[s\\] it aims to answer are:\n\n* 30-day all-cause Mortality rate\n* Composite of the following events from the time of enrolment through 12-month:\n\n  * Device Technical Success\n  * Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system\n\nParticipants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:\n\n* Physical examination\n* Modified Rankin scale\n* Tarlov scoring scale\n* CTA",[27,108,109],"Intramural Hematoma","Penetrating Aortic Ulcer","2025-02-24",{"date":112,"type":32},"2025-02-26",{"date":114,"type":32},"2024-03-08",{"date":116,"type":21},"2031-12",{"name":118,"class":39},"Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd"]