[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stent-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stent-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100539831","phase-4-atorvastatin-pretreatment-in-cerebrovascular-events-apices-after-flow-diverter-implantation-100539831",false,"NCT06308952","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation: Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion criteria:\n\n1. Aged 18 to 75 years old, male or non-pregnant female;\n2. UIA diagnosed by CTA, MRA, or DSA;\n3. Maximal aneurysmal diameter between 3 and 25mm;\n4. Understands the nature of the procedure and provision of written informed consent;\n5. Indications for FD implantation with or without adjunctive coiling;\n6. Is willing to return to the investigational site for follow-up according to our protocol.\n\nExclusion criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Contraindications to atorvastatin treatment or known allergy to atorvastatin;\n2. Pregnancy or lactation;\n3. Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);\n4. Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;\n5. Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;\n6. Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9 inhibitor, etc.), antacids, erythromycin, cytochrome P450 enzyme, colchicine, etc.);\n7. Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period;\n8. The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)\n9. Other situations that the researcher deems unsuitable for inclusion in the study (inability to receive anti-platelet or anticoagulant medication; allergy or contraindication for the use of FD alloy, history of life-threatening allergy to contrast dye, ect).\n10. Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated.\n11. Unwilling to be followed up or likely to have poor treatment compliance at initial screening;\n12. Life expectancy less than 3 years;\n13. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);\n14. Enrollment in another trial.\n\nWithdrawal criteria\n\nIn this trial, participants who have provided written informed consent but are unable to complete the entire study for any reason will be withdrawn. These circumstances include the following:\n\n1. The participants voluntarily quit the trial for various reasons;\n2. Occurrence of serious adverse events (SAEs). The study may be terminated by the participants, principal investigators, ethics committee, sponsor, or regulatory authorities based on ethical considerations;\n3. Early termination of the process based on the investigator's judgment in order to prevent development of severe complications;\n4. Significant deviation in implementation, or the subject failed to comply with the scheduled protocol;\n5. Miss the follow-up due to changes in working\u002Fliving places, or fortuitous accident (traffic accident, bone fracture, accidental death, ect.). Thus, close follow-up should be conducted to determine their relationship with the usage of FD and experimental drug;\n6. Flawed or absence of informed consents.","ALL","18 Years","75 Years",{"count":20,"type":21},354,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","APICES trial is an investigator-initiated, multicenter, multicenter, randomized, double-blind, placebo-controlled clinical trial that plans to enroll 396 patients with a 1-year follow-up, including a neurovascular imaging examination \\[digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA)\\] at 6 months after index treatment. It was designed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The study was approved by the Ethics Committee of Zhujiang Hospital of South Medical University (2024-KY-032-02) and registered at ClinicalTrials.gov (NCT06308952). The participants will be recruited from twelve advanced stroke centers in China.",[27,28,29,30,31,32,33],"Cerebrovascular Event","Stent Stenosis","Ischemic Stroke","Hemorrhagic Stroke","Stent Thrombosis","Death, Brain","Endothelial Dysfunction",[35,36,37,38],"Atorvastatin","Intracranial aneurysm","Flow-diverter devices","Stroke","RECRUITING","2026-02-27",{"date":42,"type":43},"2026-03-03","ACTUAL",{"date":45,"type":43},"2024-07-30",{"date":47,"type":21},"2027-12-31",{"name":49,"class":50},"Duan Chuanzhi","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":80,"locationsCount":82},"100501442","effects-branch-pa-stenting-d-tga-tof-and-ta-100501442","NCT05809310","Effects Branch PA Stenting d-TGA, ToF and TA","The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Patients with d-TGA post ASO, ToF or TA\n* ≥8 years\n\nExclusion Criteria:\n\nOne or more of the following inclusion criteria:\n\n* All class IIa indications for a branch PA intervention:\n* Persistent decreased RV function (based on gold standard CMR)\n\n  * \\\u003C18 years RVEF ≤55% (28)\n  * ≥18 years RVEF\\\u003C50% (29)\n* Progressive tricuspid regurgitation (TR) (≥moderate)\n* Isolated bifurcation stenosis:\n\n  * Significant unilateral stenosis (≥50%)\n  * Borderline bilateral PA stenosis (40-70%)\n* Unbalanced perfusion (≤35\u002F65%)\n* RV\u002FLV pressure ratio \\> 2\u002F3 based on echocardiography\n* Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)\n\n  * \\\u003C18 years VO2 peak \\\u003C35 mL∙kg-1∙min-1 (boys) VO2 peak \\\u003C30 mL∙kg-1∙min-1 (girls) (30)\n  * ≥18 years VO2 peak \\\u003C27 mL∙kg-1∙min-1 (men) VO2 peak \\\u003C19 mL∙kg-1∙min-1 (women) (31)","8 Years",{"count":61,"type":21},56,[63],"NA","The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.\n\nThe main question\\[s\\] it aims to answer are:\n\nThe primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.\n\nParticipants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht\u002FWKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.\n\nResearchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)",[66,67,68,69,28,70,71],"Transposition of Great Vessels","Tetralogy of Fallot","Truncus Arteriosus","Pulmonary Artery Stenosis Supravalvular Congenital","Right Ventricular Dysfunction","Congenital Heart Disease",[73],"Exercise capacity","2025-03-25",{"date":76,"type":43},"2025-03-30",{"date":78,"type":43},"2023-04-18",{"date":47,"type":21},{"name":81,"class":50},"UMC Utrecht",4]