title: Parent artery reconstruction for large or giant cerebral aneurysms using a Tubridge flow diverter (PARAT): study protocol for a multicenter, randomized, controlled clinical trial.
abstract: BACKGROUND
  The treatment of large (10-25 mm) or giant (≥25 mm) cerebral aneurysms remains technically challenging, with a much higher complication and recanalization rate than that is observed for smaller aneurysms. The use of a flow diverter seems to facilitate the treatment of this special entity. In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration (CFDA), we obtained promising results, showing remarkable safety and effectiveness for the Tubridge flow diverter. Nevertheless, the previous study may have been limited by biases due to its single-center design and limited number of subjects. Furthermore, although various articles have reported durable results from treating aneurysms using flow diverters, increasing questions have arisen about this form of treatment. Thus, prospective, multiple-center, randomized trials containing more subjects are needed.
  
  
  METHODS
  This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion rate at 6-month follow-up. Secondary endpoints include the immediate technique success rate, overall mortality, adverse events (ischemic stroke or intracranial bleeding) within 30 days, 90 days and 1 year post-operation, and the rate of intra-stent stenosis and thrombosis 6 months post-operation.
  
  
  CONCLUSIONS
  This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms.
  
  
  BACKGROUND
  The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-13003127.
authors.forename: Yu
authors.initials: Y
authors.lastname: Zhou
authors.forename: Peng-Fei
authors.initials: PF
authors.lastname: Yang
authors.forename: Yi-Bin
authors.initials: YB
authors.lastname: Fang
authors.forename: Yi
authors.initials: Y
authors.lastname: Xu
authors.forename: Bo
authors.initials: B
authors.lastname: Hong
authors.forename: Wen-Yuan
authors.initials: WY
authors.lastname: Zhao
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.forename: Rui
authors.initials: R
authors.lastname: Zhao
authors.affiliation: Department of Neurosurgery, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, P,R, China. ocinhqh@163.com.
authors.forename: Qing-Hai
authors.initials: QH
authors.lastname: Huang
authors.forename: Jian-Min
authors.initials: JM
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002536:Cerebral Arteries / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000295:instrumentation* / Q000379:methods*; D011446:Prospective Studies; D019651:Plastic Surgery Procedures; D015607:Stents; D016896:Treatment Outcome; D055815:Young Adult