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

BackgroundThe 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/DesignThis 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.DiscussionThis 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.Trial registrationThe trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-13003127

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Cerebral aneurysm treatment: modern neurovascular techniques

“…At a mean follow-up of 10 months, 72% of the aneurysms were completely occluded and 24% were improved, with 4% showing no significant change 42. After approval from the Chinese FDA, the device is currently being studied in a multicentre, randomised, controlled clinical trial 43. In this study, Zhou et al will enrol 124 patients and randomise into a treatment group consisting of Tubridge or Tubridge with coils versus a control group treated with stent-assisted coiling.…”

Evaluating the Tubridge™ flow diverter for large cavernous carotid artery aneurysms

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