[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endoleak\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endoleak":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,76,101],{"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":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100490359","endovascular-aortic-repair-with-sac-embolization-for-the-prevention-of-type-ii-endoleaks-the-evar-se-study-100490359","NCT05665101","EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)","EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany","EVAR-SE","Inclusion Criteria:\n\n* Age ≥18 years\n* Infrarenal AAA ≥50 mm maximum diameter\n* Indication for EVAR within IFU of company\n* Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and\u002For lumbar artery, and\u002For median sacral artery) or \\\u003C40% thrombus at largest AAA diameter\n\nExclusion Criteria:\n\n* Ruptured AAA\n* Fenestrated or branched EVAR\n* Concomitant iliac artery aneurysm\n* Non-ability to adhere to the FU protocol\n* Lack of consent\n* Pregnancy",{"count":56,"type":21},100,"INTERVENTIONAL",[59],"NA","Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.\n\nSecondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.",[62,26],"Abdominal Aortic Aneurysm",[62,26,64,65,66],"Endovascular aortic aneurysm repair","Coiling","Endoleak Type II",{"date":37,"type":38},{"date":69,"type":38},"2023-01-15",{"date":71,"type":21},"2028-04-30",{"name":73,"class":74},"Univ.-Prof. Dr. Dr. med. Daniela Branzan","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":57,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100591037","pre-emptive-coil-embolization-in-endovascular-aortic-repair-100591037","NCT06975215","Pre-emptive Coil Embolization in Endovascular Aortic Repair","Pre-emptive Coil Embolization in Endovascular Aortic Repair: The PRIZE Study","PRIZE","Inclusion Criteria:\n\n* Abdominal aortic aneurysms with a maximum aortic diameter above the threshold for repair level.\n* High-risk criteria for type 2 endoleaks\n\nExclusion Criteria:\n\n* Does not fulfill instructions for use for standard EVAR\n* Contraindication for EVAR\n* Life expectancy less than 2 years",{"count":85,"type":21},332,[59],"Abdominal aortic aneurysms are often treated with a minimally invasive procedure called endovascular aortic repair (EVAR). While EVAR is widely used, it can sometimes lead to complications over time, and some patients may require further procedures. One of the main issues is endoleak, which occurs when blood continues to flow into the aneurysm sac after treatment. This often happens because small nearby blood vessels, or other sources, continue to supply blood to the aneurysm.\n\nA potentialy strategy to reduce the risk of endoleak is pre-emptive embolization-a technique used during EVAR to block these sources of persistent blood flow. This can include embolization of side branches, the aneurysm sac, or other contributing vessels. Early findings suggest that pre-emptive embolization may lower the risk of endoleaks, but it is still uncertain whether it improves long-term outcomes.\n\nThe PRIZE study (Randomized Controlled Trial on Pre-emptive Coil Embolization in Endovascular Aortic Repair) is designed to answer this question. In this research, patients are randomly assigned to one of two groups: one group will receive EVAR with pre-emptive embolization, and the other will receive EVAR without it.\n\nTwo main outcomes will be assessed. The first is aneurysm sac regression at two years, meaning a reduction in the size of the aneurysm sac after treatment. This is important because sac shrinkage after EVAR has been linked to lower overall mortality, even though the exact reasons for this are not yet fully understood. The second main outcome is the rate of aortic-related events over five years, as ensuring the long-term durability of treatment is a key goal of this study. Secondary outcomes, including quality of life, patient satisfaction, and cost-effectiveness will also be evaluated.\n\nCurrently, there is no clear agreement on whether pre-emptive embolization should be routinely used during EVAR. In a recent international survey, 76% of aortic specialists agreed that more evidence is needed. The PRIZE study aims to provide that evidence. If pre-emptive embolization proves effective, it could become a standard addition to EVAR, helping to improve both the immediate success and long-term durability of treatment. If not, the study will help avoid unnecessary procedures, ensuring patients receive only treatments that offer real benefits.",[89,90,26],"Abdominal Aneurysm","Endovascular Aortic Repair","NOT_YET_RECRUITING","2025-05-07",{"date":94,"type":38},"2025-05-16",{"date":96,"type":21},"2025-09-01",{"date":98,"type":21},"2033-09-01",{"name":100,"class":74},"Uppsala University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":57,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":75},"100386151","aneufix---prophylactic-sac-filling-100386151","NCT04307992","AneuFix - Prophylactic Sac Filling","Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation","Inclusion Criteria:\n\n* Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:\n\n  \\- Open IMA AND\n  * 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \\>17,5cm2 OR\n  * 2 patent lumbars AND a CSAIMA \\>15cm2 OR\n  * 3 patent lumbars AND a CSAIMA \\>12,5 cm2 OR\n  * 4 patent lumbars AND a CSAIMA \\>10 cm2 OR\n  * 5 patent lumbars AND a CSAIMA \\>7,5 cm2\n* Infrarenal neck according to the IFU of the EVAR device\n* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used\n* Patient having a life expectation of at least 2 years\n* Being older than 18 years\n* Willing and able to comply with the requirements of this clinical study\n\nExclusion Criteria:\n\n* Patient not able or willing to give written Informed Consent\n* Patient undergoing emergency procedures\n* Patient undergoing EVAR for ruptured or symptomatic AAA,\n* Patient with a suprarenal AAA\n* Patient with an inflammatory AAA (more than minimal wall thickening)\n* Patient with an infrarenal neck unsuitable for endovascular fixation (including so called \"hostile necks\") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used\n* Patient in which a bilateral retroperitoneal incision is required for EVAR\n* Patient in which a sacrifice of both hypogastric arteries is required\n* Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation\n* Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent\n* Patient with active infection present\n* Patients scheduled for or having received an organ transplant\n* Patient with limited life expectation due to other illness (\\\u003C1 year)\n* Patient with non-iatrogenic bleeding diathesis\n* Patient with connective tissue disease\n* Women of child-bearing potential\n* Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation",{"count":109,"type":21},5,[59],"This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.",[62,26],"2024-06-06",{"date":115,"type":38},"2024-06-07",{"date":117,"type":38},"2022-02-15",{"date":119,"type":21},"2025-12-31",{"name":121,"class":45},"TripleMed B.V."]