[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ming Lv\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100548104","general-anesthesia-vs-local-anesthesia-for-endovascular-treatment-in-patients-with-unruptured-intracranial-aneurysm-using-flow-diverter-100548104",false,"NCT06416657","General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter","General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial","GALA-FD","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤80 years old, gender is not limited;\n2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;\n3. UIA maximum diameter \\\u003C15mm;\n4. Baseline mRS score ≤2;\n5. UIAs planned for treated with PED;\n6. Patients voluntarily participated in this study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;\n2. Those who are allergic to any components of the anesthetic drugs;\n3. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;\n4. Pregnant and lactating female patients;\n5. Severe hepatic dysfunction (ALT or AST \\>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \\\u003C30 mL\u002Fmin) before randomisation;\n6. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);\n7. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;\n8. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;\n9. Patients who are participating in clinical trials of other drugs or devices;\n10. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":21,"type":22},188,"ESTIMATED","INTERVENTIONAL",[25],"NA","The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.",[28],"Intracranial Aneurysm",[30,31,32,33],"Unruptured intracranial aneurysm","Flow diverter","General anesthesia","Local anesthesia","RECRUITING","2025-11-25",{"date":37,"type":38},"2025-12-02","ACTUAL",{"date":40,"type":38},"2024-06-01",{"date":42,"type":22},"2026-06-01",{"name":44,"class":45},"Ming Lv","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100547284","metformin-in-patients-with-unruptured-vertebrobasilar-dissecting-aneurysms-mettle-100547284","NCT06405971","Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms (METTLE)","Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms: a Prospective, Randomized Study (METTLE)","METTLE","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years, gender is not limited;\n2. Patients with previously untreated, unruptured stable VBDAs clearly diagnosed by DSA, CTA or MRA;\n3. Patients with aneurysm wall enhancement as shown by HR-VWI of 3.0T high field strength MRI whole body scanner at Tsinghua University;\n4. Baseline mRS score ≤2;\n5. Patients voluntarily participated in this study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with aneurysms located in non-vertebral basilar artery sites (mainly referring to bifurcation saccular aneurysms);\n2. Patients with combined diabetes or its complications;\n3. Patients who are allergic to any components in MET;\n4. Pregnant and lactating female patients;\n5. Patients with other immune diseases in combination, patients taking immunosuppressants or anti-inflammatory drugs (such as long-term use of aspirin, statin, hormones and other drugs);\n6. Target aneurysm-related symptoms were severe at the time of diagnosis, and the mRS score was ≥3;\n7. VBDAs have received interventional or surgical treatment;\n8. Those with severe allergy to the contrast agent gadolinium terlumate glucosamine (Gd-DTPA) (skin rash not counted);\n9. Those with severe renal disease resulting in renal insufficiency (glomerular filtration rate \\\u003C30ml\u002F(min·1.73m2));\n10. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);\n11. Patients known to suffer from dementia or psychiatric disorders and claustrophobia who are unable to complete the magnetic resonance examination;\n12. Patients with other serious diseases combined at the time of diagnosis and with an expected survival time of less than 1 year;\n13. Patients who are participating in clinical trials of other drugs or devices.\n14. Other conditions judged by the investigator to exist that are unsuitable for enrollment.","75 Years",{"count":57,"type":22},60,[25],"Vertebrobasilar dissecting aneurysms (VBDAs) are one of the most important causes of stroke in young and middle-aged people, and the natural history of VBDAs is complex and varied, often leading to high rates of disability and mortality. For some patients with VBDAs who are not suitable for surgical entrapment and intervention, pharmacologic therapy may be used to slow the progression of VBDAs. Metformin (MET) has been shown to act as an anti-inflammatory, anti-oxidative stress and improve vascular endothelial function by inhibiting smooth muscle cell phenotypic transformation, proliferation, migration and apoptosis, thereby reducing the incidence of intracranial aneurysms and rupture rates, and MET may be a suitable candidate. Inflammatory response plays an important role in the occurrence, development and rupture of VBDAs. Inflammatory response in the aneurysm wall can cause endothelial and smooth muscle cell injury and apoptosis, leading to degenerative changes in the vessel wall and increasing the risk of rupture of VBDAs. High-resolution magnetic resonance vessel wall imaging (HR-VWI), which can clearly show the structure of the vessel wall and reflect the active degree of inflammatory reaction in the aneurysm wall, has been widely used in the assessment of intracranial aneurysm instability. In this study, we propose to conduct a multicenter, prospective, randomized study to investigate whether MET reduces the degree of aneurysm wall inflammatory response in VBDAs by performing HR-VWI scans in patients with VBDAs and obtaining quantitative parameters reflecting the inflammatory response of the aneurysm wall.",[61],"Dissecting Aneurysm of Cerebral Artery",[63,64,65,66],"Vertebrobasilar dissecting aneurysms","Metformin","High-resolution vessel wall imaging","Inflammatory reaction","2025-02-04",{"date":69,"type":38},"2025-02-06",{"date":40,"type":38},{"date":72,"type":22},"2025-06-01",{"name":44,"class":45},""]