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临床试验/NCT05716360
NCT05716360招募中不适用

Early Postprocedural Susceptibility-Weighted Imaging and Vessel-Wall Imaging For Prediction of Complications After Flow-Diversion Treatment of Intracranial Aneurysms

Uludag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Determining Clinical Significant and Unsignificant Early Post-procedural susceptibility weighted and vessel wall imaging findings related to flow diversion treatment of intracranial aneurysms

研究概览

简要总结

Purpose: Examination of microangiopathic changes that may develop after flow-directed stenting of intracranial aneurysms with susceptibility-weighted imaging (SWI), and vessel wall imaging (VWI) of vessel wall inflammation that may be associated with stenosis in the stented vessel and rupture of the aneurysm.

Methods: SWI and VWI examinations will be performed before and after treatment in patients who are planned for flow-directing aneurysm treatment. Clinical follow-up of the cases will be performed during the first 3 months post-procedure. At the end of the 3rd month, SAG and DDG findings related to and unrelated to intracranial hemorrhage will be detected by control imaging.

详细描述

Susceptibility-weighted imaging (SWI) and vessel wall imaging (VWI) are among the most recent magnetic resonance (MR) techniques used to evaluate the cerebral vascular system (1,2). SWI; In addition to detecting the damage caused by many cerebrovascular pathologies at the microvascular level more sensitively than other imaging methods, it is the only MR sequence that can be used to differentiate blood-iron-calcification. It is the most sensitive MR sequence for iron accumulation and calcification. In addition to cerebrovascular diseases, it can be used in neurodegenerative diseases, especially parkinsonism, in the evaluation of tumoral - infective processes that can go with calcification (3). Similarly, VWI; It is used with increasing frequency in current practice in the diagnosis of pathologies affecting the vessel wall such as dissection, atherosclerotic change, inflammation and vasculitic involvement that cannot be clearly distinguished by normal vessel imaging methods (4). For both SWI and VWI, an MR device infrastructure with at least 3T magnetic field strength is required (2,5). Both techniques have limited diagnostic capabilities at magnetic field strengths up to 1.5T.

In studies conducted with VWI, it is stated that staining detected with VWI on the aneurysm wall may have predictive properties in terms of rupture (6,7). In addition, microhemorrhages detected by SWI imaging have been reported to transform into large parenchymal hemorrhages due to perfusion changes (8). Distant bleeding occurs due to perfusion change in some of the aneurysm cases that receive flow-directing therapy (9). In addition, rupture of the aneurysm may occur in some of the cases in which this treatment is applied, and stent stenocclusion may occur in some (10-11).

In the light of the above information, we aimed to evaluate the relationship between microhemorrhages, which may be a precursor of large parenchymal hemorrhages, staining of the aneurysm wall that may reflect the potential for rupture with VWI, and vessel wall staining or hematoma, which may reflect the risk of stenocclusion, with SWI examination to be performed on a 3T MR device in cases of intracranial aneurysms that were treated with flow-guided therapy, and complications developing after treatment.

References:

  1. Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30.
  2. Mandell DM, Mossa-Basha M, Qiao Y, et al. Vessel Wall Imaging Study Group of the American Society of Neuroradiology. Intracranial Vessel Wall MRI: Principles and Expert Consensus Recommendations of the American Society of Neuroradiology. AJNR Am J Neuroradiol. 2017 Feb;38(2):218-229.
  3. Mittal S, Wu Z, Neelavalli J, Haacke EM. Susceptibility-weighted imaging: technical aspects and clinical applications, part 2. AJNR Am J Neuroradiol. 2009 Feb;30(2):232-52.
  4. Lindenholz A, van der Kolk AG, Zwanenburg JJM, Hendrikse J. The Use and Pitfalls of Intracranial Vessel Wall Imaging: How We Do It. radiology. 2018 Jan;286(1):12-28.
  5. Nam Y, Gho SM, Kim DH, Kim EY, Lee J. Imaging of nigrosome 1 in substantia nigra at 3T using multiecho susceptibility map-weighted imaging (SMWI). J Magn Reson Imaging. 2017;46:528-536.
  6. Texakalidis P, Hilditch CA, Lehman V, Lanzino G, Pereira VM, Brinjikji W. Vessel Wall Imaging of Intracranial Aneurysms: Systematic Review and Meta-analysis. World Neurosurg. 2018 Sep;117:453-458.e1.
  7. Santarosa C, Cord B, Koo A, Bhogal P, Malhotra A, Payabvash S, Minja FJ, Matouk CC. Vessel wall magnetic resonance imaging in intracranial aneurysms: Principles and emerging clinical applications. Interv Neuroradiol. 2020 Apr;26(2):135-146.
  8. Lau KK, Wong YK, Teo KC, et al. Long-Term Prognostic Implications of Cerebral Microbleeds in Chinese Patients With Ischemic Stroke. J Am Heart Assoc. 2017 Dec 7;6(12):e007360.
  9. Zhou G, Su M, Yin YL, Li MH. Complications associated with the use of flow-diverting devices for cerebral aneurysms: a systematic review and meta-analysis. Neurosurg Focus. 2017 Jun;42(6):E17.
  10. Darsaut TE, Rayner-Hartley E, Makoyeva A, Salazkin I, Berthelet F, Raymond J. Aneurysm rupture after endovascular flow diversion: the possible role of persistent flows through the transition zone associated with device deformation. Interv Neuroradiol. 2013 Jun;19(2):180-5.
  11. Klisch J, Turk A, Turner R, Woo HH, Fiorella D. Very late thrombosis of flow-diverting constructs after the treatment of large fusiform posterior circulation aneurysms. AJNR Am J Neuroradiol. 2011 Apr;32(4):627-32.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Endovascular treatment plan with stent for intracranial aneurysm No kidney dysfunction history No MRI contrast material allergy history

排除标准

  • Pregnancy History of MR contrast material allergy Kidney dysfunction Leave Following-up During Study

结局指标

主要结局

Determining Clinical Significant and Unsignificant Early Post-procedural susceptibility weighted and vessel wall imaging findings related to flow diversion treatment of intracranial aneurysms

时间窗: Post-procedural First Three Months

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rifat Ozpar

Assistant Professor

Uludag University

研究点 (1)

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