NL-OMON24360招募中不适用
Cohort study for the treatment of unruptured intracranial aneurysms with flow diverters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Radboudumc
- 入组人数
- 83
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Suitability for FD treatment or alternative treatment will be identified according to the following inclusion criteria:
- •- unruptured intracranial aneurysm of internal carotid artery;
- •- unfavourable dome neck configuration (=2), or neck =4 mm, or maximum aneurysm diameter =10 mm; or tandem aneurysms with any configuration; multisegmental disease;
- •- =18 years;
- •- modified Rankin Scale (mRS) =2;
- •- patients willing to provide written informed consent and comply with follow up requirements.
- •Patients eligible for FD but treated otherwise in the Radboudumc and patients eligible for this study and treated with FD in other centres should also be included in the study. A registry will be kept of patients treated with FD who did not meet the inclusion criteria for this study.
排除标准
- •- intracranial hemorrhage within 30 days;
- •- presence of untreated ruptured intracranial aneurysm;
- •- =1 intracranial aneurysm except the target one which requires treatment within 12 months;
- •- contra-indication for dual antiplatelet therapy;
- •- known allergy or inadequate response to aspirin, heparin, clopidogrel, ticagrelor or prasugrel, other anti-platelet or P2Y12 agents or to general anesthesia (platelet reactivity will be assessed prior to the inclusion in patients who require anti-platelet or P2Y12 agents following the treatment);
- •- bifurcation aneurysm (e.g. pcom aneurysm with fetal or intermediate configuration where pcom cannot be occluded);
- •- immunosuppressive disease;
- •- active infectious disease (e.g. endocarditis, meningitis);
- •- platelet count < 100 x 103 cells/mm3 or known platelet dysfunction at time of enrollment;
- •- female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant;
- •- intracranial aneurysm correlating to arteriovenous malformation, dissecting aneurysms;
- •- patient with another unrelated intracranial disease and patients with any type of malignancy;
- •- major surgery within previous 30 days or planned in the next 120 days after enrolment;
- •- patient with a periprocedural International Normalized Ratio (INR)= 1.5;
- •- patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, protrombotic conditions, e.g. factor 5 Leiden);
- •- patient with a life threatening allergy to iodinated contrast media (patients with itching or rash as a reaction to contrast can be included if properly prophylactically treated);
- •- patient who is currently participating in another clinical research study involving an investigational product;
- •- stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date;
- •- unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days unrelated to the aneurysm);
- •- patient who has participated in a drug study within the last 30 days;
- •- inability to understand the study or history of non-compliance with medical advice;
- •- patient who has had a previous intracranial procedure associated with the target aneurysm such that access and placement of an investigational device would be compromised.
研究者
相似试验
尚未招募
不适用
A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo methodITMCTR2100005066Zhejiang Chinese Medical University
已完成
不适用
Prospective cohort study of standard therapy for primary malignant brain tumor patientJPRN-UMIN000030170Japan Photodynamic Neurosurgical Society100
招募中
Unknown
Clinical study on the treatment of short-term insomnia with electroacupuncture combined with cognitive behavioral therapy for insomnia.ITMCTR2024000049Dongzhimen Hospital
尚未招募
不适用
Retrospective study on the treatment of patients in specialized outpatient pain therapyChronic PainDRKS00031186Charité - Universitätsmedizin Berlin3,000
已完成
不适用
Retrospective study to systematize treatment for pain with questionnairesJPRN-UMIN000032058Fujita Health University School of Medicine Department of Anesthesiology and Critical Care Medicine600