[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lifetech Scientific (Shenzhen) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":393},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,68,97,121,147,169,191,217,242,264,283,304,324,345,368],{"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":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100523693","cera-vascular-plug-system-post-market-clinical-follow-up-100523693",false,"NCT06099015","Cera™ Vascular Plug System Post-Market Clinical Follow-Up","Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study","Inclusion Criteria:\n\n1. Aged 18 to 85;\n2. Life expectancy \\> 1 year;\n3. Require arterial or venous embolization in the peripheral vasculature;\n4. Target embolization site(s) allow for safe insertion of the delivery catheter;\n5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement;\n6. Willing and able to comply with protocol requirements, including all study visits and procedures.\n7. Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.\n\nExclusion Criteria:\n\n1. The subject is pregnant or plan to be pregnant or breast feeding;\n2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;\n3. The subject has a known allergy or hypersensitivity to contrast agent;\n4. The subject has uncorrectable coagulopathy;\n5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and\u002For after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints\n6. The subject has an unresolved systemic infection;\n7. Subject who cannot tolerate general or local anesthesia;\n8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;\n9. The subject is participating in other drug or medical device clinical trials;\n10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.","ALL","18 Years","85 Years",{"count":20,"type":21},132,"ESTIMATED","OBSERVATIONAL","The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to:\n\n* confirm the performance\n* confirm the safety\n* identify previously unknown side-effects\n* monitor the identified side-effects (related to the procedures or to the medical devices)\n* identify and analyse emergent risks",[25,26,27,28,29,30],"Aneurysm","Endoleak","Pulmonary Arteriovenous Malformation","Portal Hypertension","Arteriovenous Fistula","Splenic Laceration",[32,33],"Lifetech","Cera Vascular Plug","RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-12","ACTUAL",{"date":40,"type":38},"2024-06-21",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100641895","heartr-pda-occluder-post-market-follow-up-study-100641895","NCT07646704","HeartR™ PDA Occluder Post-Market Follow-Up Study","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions\n2. Age ≥ 6 months at the time of implantation.\n3. Weighing ≥ 6 kg at the time of implantation.\n4. Narrowest portion of the PDA ≥ 2mm at the time of implantation.\n\nExclusion Criteria:\n\nPatients did not conduct any follow up visit after hospital discharge.","6 Months",{"count":55,"type":21},140,"The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled.\n\nEligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study.\n\nThe primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke\u002FTIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure\u002Fdevice-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.\n\nSecondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.",[58],"Patent Ductus Arteriosus","2026-06-09",{"date":61,"type":38},"2026-06-15",{"date":63,"type":38},"2025-04-30",{"date":65,"type":21},"2026-12-31",{"name":44,"class":45},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":67},"100622590","fim-study-of-the-lambre-ii-laa-occluder-in-non-valvular-af-patients-100622590","NCT07385599","FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients","A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation","Inclusion Criteria:\n\n1. The patient age ≥18 years;\n2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n3. The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;\n4. The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;\n5. The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the patient's medical record;\n6. The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n7. The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)\n\nExclusion Criteria:\n\n1. Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index procedure;\n2. Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism);\n3. Patients who require long-term anticoagulation for a condition other than atrial fibrillation;\n4. Bleeding diathesis or coagulopathy;\n5. Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;\n6. Active infection with bacteremia;\n7. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast sensitivity;\n8. Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;\n9. Left atrial appendage is obliterated and surgical ligated;\n10. Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.);\n11. Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n12. New York Heart Association Class IV;\n13. Patients with severe renal failure (estimated glomerular filtration rate\\\u003C30 ml\u002Fmin\u002F1.73m2);\n14. Known asymptomatic carotid artery disease with\\>70% diameter stenosis OR symptomatic carotid disease (\\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \\\u003C50%;\n15. Life expectancy is less than 1 year;\n16. Current participation in another investigational drug or device study.",{"count":76,"type":21},10,"INTERVENTIONAL",[79],"NA","To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.",[82],"Non-valvular Atrial Fibrillation (NVAF)",[32,84,85,86,87,88,89],"FIM study","LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System","LAmbre™ II","LAmbre™ II Left Atrial Appendage Occluder","Left Atrial Appendage Occluder","LAmbre™ II LAAO","2026-06-08",{"date":35,"type":38},{"date":93,"type":38},"2026-01-19",{"date":95,"type":21},"2028-03-01",{"name":44,"class":45},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100525325","ceraflex-pfo-closure-system-pmcf-study-100525325","NCT06120270","CeraFlex PFO Closure System PMCF Study","CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study","Inclusion Criteria:\n\n1. Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):\n\n   1. Confirmed PFO by medical examinations;\n   2. Associated with recurrent migraine\u002Fheadache or TIA or cryptogenic stroke.\n2. Patient characteristics consistent with the corresponding IFU \\& Device Size Selection:\n\n   1. Measure the distance from the defect to the aorta root;\n   2. Measure the distance from the defect to the superior vena cava (SVC) rim; select a device with the radius of the right disc that will not exceed the lesser of these two distances.\n3. Patients who are willing to comply with all study procedures and be available for the duration of the study.\n4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years or Age \\>85 years.\n2. Patient with a history of ongoing Atrial Fibrillation (AF).\n3. Patient with malignancy or other illness where life expectancy is less than 1 year.\n4. Patient not covered by a social security scheme.\n5. Patients who are participating in an investigational drug or device study currently.\n6. Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).\n7. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.\n8. Any contraindication mentioned in the corresponding IFU：\n\n   1. Patients known to have intracardiac thrombi, especially left atrial or left atrial appendage thrombi, demonstrated by echocardiography. Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.\n   2. Anatomy in which the CeraFlexTM PFO device of the required size would interfere with intra-cardiac structure or intra-vascular structure, such as a pulmonary vein, or aorta root.\n   3. Patients whose heart or vein size is too small to allow TEE probing or catheterization.\n   4. Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.\n   5. Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.\n   6. Patients whose heart does not have enough tissue to secure the device.\n   7. Patients with hypercoagulation disease.\n   8. Any patient for whom the radius of the device is greater than the distance from the patent foramen ovale to the aortic root or superior vena cava.\n\n      * No contraindications specified in the SteerEase introducer IFU.",{"count":105,"type":21},180,"The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.",[108],"Patent Foramen Ovale",[32,108,110,111,112,113],"PFO","CeraFlex","CeraFlex PFO","CeraFlex PFO Closure System",{"date":35,"type":38},{"date":116,"type":38},"2023-11-03",{"date":118,"type":21},"2028-12",{"name":44,"class":45},15,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":77,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":67},"100570722","thoracoabdominal-artery-stent-graft-system-exploratory-study-100570722","NCT06710938","Thoracoabdominal Artery Stent Graft System Exploratory Study","Exploratory Study of Thoracoabdominal Artery Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysms","Inclusion Criteria:\n\n1. Age: 18 to 80 years old;\n2. Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:\n\n   1. Maximum diameter of TAAA is \\>50 mm;\n   2. TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;\n   3. Definite symptoms associated with TAAA, such as abdominal pain and back pain.\n3. Anatomical Criteria\n\n   1. Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;\n   2. Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm.\n   3. Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;\n   4. Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;\n   5. Appropriate iliac, femoral, and upper limb arterial access.\n4. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;\n5. Patients do not want to or cannot wait for the approved alternative\n\nExclusion Criteria:\n\nExclusion Criteria (not eligible if any of the criteria is met):\n\n1. Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;\n2. Patients with thoracoabdominal aortic dissection;\n3. Patients with infected or mycotic thoracoabdominal aortic aneurysms;\n4. Patients with systemic or local infections that may increase the risk of endovascular graft infection;\n5. Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;\n6. Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;\n7. Patients with severe stenosis, calcification or mural thrombus at stent-graft landing zone, and this situation leads to difficulty in adhering the covered stent or affecting the patency of the stent;\n8. Patients with a history of acute coronary syndrome within the recent 6 months; Acute coronary syndrome refers to acute cardiac ischemic syndrome caused by rupture or erosion of unstable atherosclerotic plaques in the coronary artery and fresh thrombosis, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris.\n9. Patients with transient ischemic attack (TIA) or ischemic\u002Fhemorrhagic stroke within the recent 3 months;\n10. Patients with abnormal liver and kidney function before operation \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal value; Serum creatinine (Cr) \\>150umol\u002FL\\];\n11. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;","80 Years",{"count":130,"type":21},11,[79],"This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).",[134],"Thoracoabdominal Aortic Aneurysms",[134,136,137,138],"G-branch Stent Graft","Lifetech Scientific","Thoracoabdominal Artery Stent Graft System","2026-05-21",{"date":141,"type":38},"2026-05-26",{"date":143,"type":38},"2025-07-24",{"date":145,"type":21},"2032-06-30",{"name":44,"class":45},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100507462","lifetech-ceraflex-asd-closure-system-post-market-clinical-follow-up-100507462","NCT05887700","Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up","A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.\n2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.\n\nExclusion Criteria:\n\nPatients did not conduct any follow up visit after hospital discharge.",{"count":155,"type":21},145,"The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.",[158],"Atrial Septal Defect",[32,158,160,111,161],"ASD","ASD Closure System",{"date":141,"type":38},{"date":164,"type":38},"2024-07-09",{"date":166,"type":21},"2027-06-30",{"name":44,"class":45},5,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":77,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100633618","safety-and-efficacy-of-the-absnowtm-ii-absorbable-atrial-septal-defect-closure-system-for-atrial-septal-defect-closure-therapy-100633618","NCT07529028","Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy","A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the AbsnowTM II Absorbable Atrial Septal Defect Occluder System for Atrial Septal Defect Closure Therapy","Inclusion Criteria:\n\n1. Aged≥3years, body weight≥10 kg, regardless of gender;\n2. Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement);\n3. ASD diameter≥5 mm and\\\u003C26 mm;\n4. The distance from the ASD rim to the openings of the superior\u002Finferior vena cava and pulmonary veins≥5mm, and the distance to the atrioventricular valve≥7mm;\n5. Patients who can understand the trial purpose, voluntarily participate and sign the informed consent form, and are willing to cooperate with follow-up completion.\n\nExclusion Criteria:\n\n1. Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD);\n2. Patients with ASD diameter≥26 mm;\n3. Combined with other structural heart diseases requiring treatment besides ASD;\n4. Complicated with severe pulmonary hypertension or Eisenmenger syndrome;\n5. Patients who suffered from infectious diseases within 1 month before enrollment, including infective endocarditis, or those with uncontrolled infectious diseases;\n6. Patients who suffered from hemolysis, hemorrhagic diseases, unhealed peptic ulcer within 1 month before enrollment, or have any contraindications to aspirin therapy (except those who can take other antiplatelet drugs continuously for 6 months);\n7. Intracardiac thrombus detected by echocardiography (especially thrombus in the left atrium or left atrial appendage), or venous thrombosis at the catheter insertion site;\n8. Patients allergic to the materials of the investigational medical device;\n9. Pregnant or lactating females, or those who plan to have children during the trial and are unwilling to adopt effective contraceptive measures;\n10. Patients who participated in other drug or medical device clinical trials before enrollment and have not reached the primary endpoint;\n11. Patients with other factors deemed inappropriate to participate in this clinical trial by the investigator.","3 Years",{"count":178,"type":21},236,[79],"A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy. A parallel controlled comparison will be conducted using the Cera atrial septal defect occluder manufactured by the same company as the control device, to evaluate the safety and efficacy of the AbsnowTM II absorbable ASD occluder system in the treatment of ASD occlusion.",[158],"NOT_YET_RECRUITING","2026-04-07",{"date":185,"type":38},"2026-04-14",{"date":187,"type":21},"2026-04",{"date":189,"type":21},"2031-12",{"name":44,"class":45},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":198,"targetDuration":4,"studyType":77,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100556106","concave-supra-arch-branched-stent-graft-system-for-endovascular-treatment-of-aortic-arch-diseases-100556106","NCT06520774","Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases","A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases","Inclusion Criteria:\n\n1. Patients who are aged 18 to 80 years inclusive；\n2. Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;\n3. Anatomical criteria, including:\n\n   1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);\n   2. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;\n   3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;\n   4. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;\n   5. Have a suitable iliac, femoral, and superior arch arterial access;\n4. At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;\n5. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients either with ruptured or infected aneurysms;\n2. Patients with aortic dissection;\n3. Patients with general or local infections that may increase the risk of endovascular graft infection;\n4. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;\n5. Previous endovascular intervention involving the aortic arch;\n6. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;\n7. Patients with a history of stroke within the past 3 months (excluding TIA);\n8. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;\n9. Patients with a history of myocardial infarction within the past 3 months;\n10. Patients with congestive heart failure - NYHA Class IV;\n11. Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);\n12. Patients with contraindications to anticoagulant or antiplatelet drugs;\n13. Patients unable to tolerate general anesthesia;\n14. Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) \\>150umol\u002FL);\n15. Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;\n16. Patients with arteritis;\n17. Patients with a life expectancy of less than 1 year;\n18. Women who are planning to conceive, pregnant or breastfeeding;\n19. Patients deemed by the investigator as unsuitable for endovascular treatment;\n20. Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.",{"count":199,"type":21},103,[79],"The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases",[203,204],"Aortic Arch Aneurysm","Penetrating Aortic Ulcer",[32,206,207],"Concave Supra-arch Branched Stent-Graft System","Endovascular Treatment","2025-07-25",{"date":210,"type":38},"2025-07-28",{"date":212,"type":38},"2024-05-30",{"date":214,"type":21},"2031-06-30",{"name":44,"class":45},17,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":224,"targetDuration":4,"studyType":77,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":67},"100501000","thoracoabdominal-aortic-stent-system-for-endovascular-treatment-of-thoracoabdominal-aortic-dissecting-aneurysm-100501000","NCT05803564","Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.","Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.","Inclusion Criteria:\n\n1. Patients aged greater than 18 years old and less than 80 years old;\n2. Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:\n\n   a)Maximum aneurysm diameter \\>50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.\n\n   d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter \\>40 mm;\n3. Anatomic criteria\n\n   a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\\~36 mm to ≥25 mm in length; b）Distal anchoring area (aorta or implanted graft): If distal anchoring area is in iliac artery, anchoring area diameter range 7\\~25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12\\~36 mm and a length of ≥20 mm; c）There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6\\~13 mm and the length is ≥15 mm.\n\n   d）Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5\\~9 mm, length ≥15 mm; e）Suitable iliac, femoral, and upper limb arterial access.\n4. Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;\n\nExclusion Criteria:\n\n1. Patients with severe hematoma in aortic wall in proximal anchoring area of stent\n2. Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;\n3. Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.\n4. Patients with a transient ischemic attack (TIA) or ischemic\u002Fhemorrhagic stroke within 3 months;\n5. Patients with preoperative hepatic and renal dysfunction \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the normal upper limit; Serum creatinine (Cr) \\>150u mol\u002FL\\];\n6. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;\n7. Patients with severe coagulopathy;\n8. Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials);\n9. Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease;\n10. Patients with arteritis;\n11. Patients with significant organ dysfunction or other serious disease;\n12. Women with planned pregnancy, pregnancy stage , or lactation;\n13. The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this trial.\n14. Patients with a life expectancy of not more than 1 year;\n15. Patients judged by the investigator to be unsuitable for endovascular treatment;",{"count":225,"type":21},46,[79],"A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.",[229],"Thoracoabdominal; Aortic, Aneurysm, Dissecting",[231,232,233],"Thoracoabdominal aortic stent system","thoracoabdominal aortic dissecting aneurysm","G-Branch","2025-06-17",{"date":236,"type":38},"2025-06-22",{"date":238,"type":38},"2021-10-01",{"date":240,"type":21},"2027-10-01",{"name":44,"class":45},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":249,"targetDuration":4,"studyType":77,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":67},"100443483","safety-and-efficacy-of-a-multi-branched-thoracoabdominal-stent-graft-system-for-thoracoabdominal-aortic-aneurysm-100443483","NCT05054985","Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.","Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 80 years old;\n2. Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;\n\n   1. Maximum diameter of thoracoabdominal aortic aneurysm\\>50mm;\n   2. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;\n3. anatomical criteria\n\n   1. The proximal anchoring region (aorta or implanted graft) was 17\\~36 mm in diameter and ≥25 mm in length;\n   2. Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\\~36mm and the length≥ 20mm;\n   3. The diameter of the vessel anchoring area of the visceral branch ranges from 6\\~13 mm and the length ≥15 mm;\n   4. The diameter of renal artery anchoring area ranges from 4.5\\~9mm, and the length ≥15 mm;\n   5. Appropriate iliac, femoral and upper limb artery access;\n4. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;\n\nExclusion Criteria:\n\n1. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;\n2. Thoracoabdominal aortic dissection;\n3. Mycotic or infectious thoracoabdominal aortic aneurysm;\n4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;\n5. Superior mesenteric, celiac, or renal artery occlusion;\n6. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;\n7. Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;\n8. A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.\n9. Transient ischemic attack (TIA) or ischemic\u002Fhaemorrhagic stroke within 3 months;\n10. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol\u002FL;\n11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;\n12. Severe coagulation dysfunction;\n13. Undergone major surgical or interventionic surgery within 30 days before surgery;\n14. A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);\n15. Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;\n16. takayasu arteritis;\n17. Serious vital organ dysfunction or other serious disease;\n18. Planning pregnancy, pregnancy, or breastfeeding;\n19. Patients who participated in other clinical trials and was not discontinued or withdrawn within the first 3 months of the screening period of this trial.\n20. Life expectancy less than 1 year;\n21. Patients who, in the judgment of the investigator, are not eligible for endotherapy.",{"count":250,"type":21},73,[79],"Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.",[134],[255,256,257],"Guo's Visceral Arteries Reconstruction","Multi-branched Thoracoabdominal Stent Graft System","Thoracoabdominal Aortic Aneurysm",{"date":236,"type":38},{"date":260,"type":38},"2021-11-12",{"date":262,"type":21},"2028-12-31",{"name":44,"class":45},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":271,"targetDuration":4,"studyType":77,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":281,"leadSponsor":282,"locationsCount":67},"100586451","study-on-the-aortic-arch-single-branch-stent-graft-system-100586451","NCT06915545","Study on the Aortic Arch Single Branch Stent Graft System","Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch","Inclusion Criteria:\n\n* Age between 18 and 80 years, gender unrestricted.\n* Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.\n* Anatomical criteria:\n\n  * The diameter range of the proximal aortic landing zone is 20-42 mm.\n  * The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.\n  * The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.\n  * The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.\n  * Suitable access to the femoral artery, iliac artery, and upper limb artery.\n* Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.\n\nExclusion Criteria:\n\n* Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.\n* Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.\n* Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).\n* Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.\n* Patients who have received abdominal aortic surgical or endovascular interventional surgery within the past 3 months.\n* Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.\n* Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).\n* Patients known to have contraindications to anticoagulant and antiplatelet drugs.\n* Patients intolerant to general anesthesia.\n* Patients with severe abnormalities in liver, kidney, and cardiac function before the operation \\[Subjects with a serum creatinine level exceeding 150 μmol\u002FL; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.\\].\n* Patients whose expected lifespan is shorter than 1 year.\n* Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.\n* Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.\n* Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present study.",{"count":272,"type":21},135,[79],"The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch",[276],"Aortic Dissection","2025-06-10",{"date":279,"type":38},"2025-06-11",{"date":63,"type":38},{"date":214,"type":21},{"name":44,"class":45},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},"100581386","cera-asd-occluder-post-market-clinical-follow-up-study-100581386","NCT06849635","Cera™ ASD Occluder Post-Market Clinical Follow-Up Study","Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).\n* Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.\n* Patients or legally authorized representative are willing to the collection and processing of his\u002Fher data or sign the Informed Consent.\n\nExclusion Criteria:\n\n* Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.\n* Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.\n* Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.\n* Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).\n* Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.\n* Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.\n* Patients did not conduct any follow up visit after hospital discharge.",{"count":291,"type":21},139,"The objective of this post-market study is to:\n\n* collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder\n* identify previously unknown side-effects",[158],[158],"2025-03-03",{"date":297,"type":38},"2025-03-06",{"date":299,"type":38},"2025-01-03",{"date":301,"type":21},"2026-02-28",{"name":44,"class":45},6,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":168},"100569894","lifetech-acumark-sizing-balloon-post-market-clinical-follow-up-study-100569894","NCT06700174","Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study","A Multicenter, Prospective, Single-arm, Observational Study","Inclusion Criteria:\n\n1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;\n2. The anatomy of ASD is suitable for percutaneous closure;\n3. Patients are scheduled to perform ASD closure;\n4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Any contraindication for ASD closure;\n2. Patients have ostium primum ASD or coronary sinus ASD;\n3. Patients who are pregnant or breastfeeding;\n4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.",{"count":312,"type":21},100,"The objective of this PMCF study is to:\n\n* confirm the safety and performance of the AcuMarkTM Sizing Balloon\n* identify previously unknown side-effects\n* monitor the identified side-effects (related to the procedure or to the medical devices)",[315],"Atrial Septal Defect (ASD)","2024-11-19",{"date":318,"type":38},"2024-11-21",{"date":320,"type":38},"2024-09-24",{"date":322,"type":21},"2025-03-31",{"name":44,"class":45},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":331,"targetDuration":4,"studyType":77,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":67},"100552860","study-on-multibranched-stent-graft-system-in-the-treatment-of-thoracoabdominal-aortic-aneurysm-100552860","NCT06478576","Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm","GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm","Inclusion Criteria:\n\n1. Age ≥18 and ≤80 years;\n2. Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:\n\n   1. Maximum diameter of TAAA \\>50 mm,\n   2. Rapid growth of sac \\>5 mm in diameter in the most recent 6 months, or rapid growth \\>10 mm in diameter within 1 year\n   3. Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.\n3. Anatomical criteria, including:\n\n   1. Proximal landing zone 17-36 mm in diameter and ≥25 mm in length\n   2. If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length\n   3. Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length\n   4. Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length\n4. Patients with Feasible iliofemoral artery and upper patent upper extremity access;\n5. 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 requirements of the protocol;\n\nExclusion Criteria:\n\n1. Ruptured aortic aneurysm in unstable haemodynamic condition;\n2. Aneurysmal aortic dissection;\n3. Infected or mycotic aortic aneurysm;\n4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;\n5. Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.\n6. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;\n7. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;\n8. Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.\n9. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;\n10. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol\u002FL;\n11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;\n12. Severe coagulation dysfunction;\n13. Undergone major surgical or interventionic surgery within 30 days before surgery;\n14. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);\n15. Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;\n16. Patients with takayasu arteritis;\n17. Patients with serious vital organ dysfunction or other serious disease;\n18. Planning pregnancy, pregnancy, or breastfeeding;\n19. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;\n20. Life expectancy less than 1 year;\n21. Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.",{"count":250,"type":21},[79],"The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)",[257],[32,336,207],"multibranched stent graft system","2024-07-10",{"date":339,"type":38},"2024-07-12",{"date":341,"type":38},"2023-06-01",{"date":343,"type":21},"2028-05-30",{"name":44,"class":45},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":77,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"100498748","safety-and-efficacy-of-cera-patent-foramen-ovale-occluders-100498748","NCT05774288","Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.","Inclusion Criteria:\n\n1. Patients aged 18-60 years;\n2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;\n3. Patent foramen ovale was confirmed by at least one of the following conditions exists:\n\n   1. Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);\n   2. The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);\n4. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:\n\n   1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;\n   2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;\n   3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;\n   4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.\n\nExclusion Criteria:\n\n1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\\> 50%);\n2. Large cerebral infarction occurred within 4 weeks (MR\u002FCT or DWI image ASPECTS score \\\u003C6 points or infarction volume ≥70 ml or infarction area \\> 1\u002F3 middle cerebral artery blood supply area);\n3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;\n4. Acute myocardial infarction or unstable angina within 6 months;\n5. Left ventricular aneurysm formation or left ventricular wall movement disorder;\n6. Mitral\u002Faortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;\n7. Dilated cardiomyopathy, LVEF \\\u003C 35%, or other severe heart failure;\n8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;\n9. Atrial fibrillation\u002Fatrial flutter (chronic or intermittent);\n10. Pregnant or planning to become pregnant during the trial;\n11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;\n12. Pulmonary hypertension or patent foramen ovale was a special channel;\n13. Liver and kidney function impairment (ALT or AST \\> 3 times the upper limit of normal value, serum creatinine (Cr) \\> 2 times the upper limit of normal value);\n14. Uncontrolled hypertension (\\> 180\u002F100 mmHg);\n15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;\n16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;\n17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;\n18. Thrombosis exists at the location or route of implantation;\n19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;\n20. Patients who could not be followed up during the trial;\n21. Participate in clinical trials of other drugs or medical devices within three months.","60 Years",{"count":354,"type":21},244,[79],"To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;",[108,358],"Cryptogenic Stroke","2023-08-31",{"date":361,"type":38},"2023-09-01",{"date":363,"type":38},"2023-06-08",{"date":365,"type":21},"2029-06-30",{"name":44,"class":45},14,{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":377,"conditions":378,"keywords":381,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":168},"100405428","left-atrial-appendage-closure-as-secondary-prevention-of-atrial-fibrillation-related-embolic-events-100405428","NCT04559243","Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events","A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female;\n* Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;\n* Indications for left atrial appendage closure;\n* Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;\n\n  1. HAS-BLED bleeding risk score ≥ 3 points;\n  2. Not suitable for long-term oral anticoagulant therapy;\n  3. Poor compliance with oral anticoagulants;\n  4. CHA2DS2-VASc score ≧ 2 points;\n\nExclusion Criteria:\n\n* Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)\n* Initial AF, reversible AF with clear cause\n* Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus\n* ST elevation myocardial infarction, ≤ 3 months\n* Grade-IV of Cardiac Function (NYHA)\n* Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants\n* Pregnant or with plan of pregnancy during the study\n* Participation in another drug or medical device clinical trial or study that has not been completed\n* Experience new stroke or TI within 30 days or major bleeding events within 14 days\n* Contraindication to LAA closure or deemed unsuitable for study participation by the investigator\n* Had a definite thromboembolic event",{"count":376,"type":21},579,"This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.",[379,380],"Non-valvular Atrial Fibrillation","Embolic Stroke",[382,383,384],"AF-related embolic events","non-valvular atrial fibrillation","Left Atrial Appendage Closure","2022-12-15",{"date":387,"type":38},"2022-12-19",{"date":389,"type":38},"2020-11-12",{"date":391,"type":21},"2027-11",{"name":44,"class":45},""]