The RISE trial: A Randomized Trial on Intra-Saccular Endobridge devices

Abstract

<jats:sec><jats:title>Background</jats:title><jats:p> Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed to improve on the results of coiling, including stenting and flow diversion of the parent vessel. Surgical clipping is commonly performed for certain WNBAs, such as middle cerebral aneurysms, in some centres. Intra-saccular flow diversion (ISFD) using the Woven Endo-Bridge (WEB) or similar devices, has been developed as a new endovascular alternative to coiling for WNBAs. Meta-analyses of case series suggest satisfactory results, both in terms of safety and efficacy, but in the absence of randomized evidence, whether ISFD leads to better outcomes for patients with WNBA remains unknown. There is a need to offer ISFD within the context of a randomized care trial. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> The proposed trial is a multicentre, randomized controlled care trial comparing ISFD and best conventional management option (surgical or endovascular), as determined by the treating physician prior to randomized allocation. At least 250 patients will be recruited in at least 10 centres over a four-year period, and followed for one year, to show that ISFD can increase the incidence of successful therapy from 75 to 90% of patients, defined as complete or near-complete occlusion of the aneurysm AND a good clinical outcome (mRS ≤ 2) at one year. The trial will be followed by an independent data safety monitoring committee to assure the safety of participants. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Introduction of intra-saccular flow diversion can be accomplished within a care trial context. </jats:p></jats:sec>

Microsurgical clipping versus newer endovascular techniques in treatment of unruptured anterior communicating artery-complex aneurysms: a meta-analysis and systematic review

“…Although, only 5 studies with ES treatment were included in our analysis, we observed total occlusion in 49% and 52.6% of patients in the immediate period and at 12 months' follow-up respectively. Despite our results are not statistically significant due to the unrepresentative sample, they are in line with the RISE trial, reporting successful results with intrasaccular flow disruptor device in 75-91% of cases [38]. Asnafi et al, in their systematic review and meta-analysis of WEB device in treating intracranial aneurysms, reported midterm complete occlusion rate of 39% but described a significant difference between ruptured and unruptured groups [39].…”

Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study

“…However, only 2/61 (3.3%) of the included aneurysms were ruptured 6. There is an ongoing pragmatic randomized controlled trial on using the WEB device for both ruptured and unruptured aneurysms 7. While awaiting the results from this trial, we aim to study the radiologic and clinical outcomes of patients with ruptured aneurysms compared with unruptured aneurysms treated with the WEB device, using data from an international multicenter consortium 8…”

The Woven EndoBridge Device for the Treatment of Intracranial Aneurysms: Initial Clinical Experience within an Australian Population

“…19 The multicenter Canadian-led RISE trial-a randomized controlled trial comparing intra-saccular flow diversion versus conventional management (surgical or endovascular) is currently underway and seeks to determine whether intravascular flow diversion leads to better long-term outcomes. 20 Known complications of the WEB device include failed deployment, thromboembolic events, and intracranial hemorrhage either from aneurysm rupture or vessel perforation. Goertz et al 21 report a lower aspect ratio and an increased width to height ratio are significant risk factors for procedural complications.…”

“…Stent-assisted coiling can offer high long-term complete aneurysmal occlusion; however, 12-month morbidity and mortality rates reported with its use in wide-necked aneurysms (7.5%) are considerably higher than that of coiling (1.5%) with WEB [ 19 ]. The multicenter Canadian-led RISE trial—a randomized controlled trial comparing intra-saccular flow diversion versus conventional management (surgical or endovascular) is currently underway and seeks to determine whether intravascular flow diversion leads to better long-term outcomes [ 20 ].…”