Treatment of Symptomatic Intracranial Atherosclerotic Stenosis with a Normal-Sized Gateway™ Balloon and Wingspan™ Stent

Abstract

The safety and performance of angioplasty using a normal-sized Gateway(™) balloon and Wingspan(™) stent for intracranial atherosclerotic stenosis were assessed. Seventy-two patients with intracranial stenosis (≥ 50%) were treated using an undersized (group U) or normal-sized (group N) Gateway(™) balloon and a Wingspan(™) stent. All patients were successfully stented. Stenosis improved from 74.2% before treatment to 23.8% immediately after treatment in group U and from 70.9% to 20.1% in group N. The two groups had similar rates of major periprocedural neurological complications (9.0% overall), none of which led to death. Residual stenosis at follow-up was 40.8% and 32.5% in groups U and N, respectively. In-stent re-stenosis (ISR) was significantly less frequent in group N (22.0%) than in group U (33.3%). It is concluded that use of a normal-sized Gateway(™) balloon and Wingspan(™) stent appears to be safe, to have a high rate of technical success, good immediate post-operative results and a low ISR rate.

Multiple predictors of in-stent restenosis after stent implantation in symptomatic intracranial atherosclerotic stenosis

“…Previous studies have shown that ISR is related to multiple factors such as age, stenosis location, and stent diameter. 7,8 Inflammation plays an important role in the process of ISR, and the mechanism of inflammation is neointimal hyperplasia. 9 Recently, high-sensitivity C-reactive protein (hs-CRP), one of the most representative inflammatory markers, 10 has been preliminarily found to be associated with intracranial ISR.…”

Trends in Intracranial Stenting Among Medicare Beneficiaries in the United States, 2006–2010

“…13 Under an HDE application for patients who are refractory to medical therapy, the Wingspan Stent System was approved by the FDA in 2005 on the basis of a single, uncontrolled, 45subject trial that was not designed to demonstrate whether utilization of the device was safer or more effective than medical therapy alone. 15,16 Most of the studies conducted before and after the Wingspan device was approved either had no control group that received medical therapy alone 15,[17][18][19][20][21][22] or involved comparison with a historical 9,23 or a nonrandomized 24 control group. Thus, valid conclusions could not be drawn regarding the relative safety or efficacy of stenting over standard medical therapy alone.…”

Intracranial Angioplasty and Stent Placement After Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial: Present State and Future Considerations⋆

“…The SAMMPRIS trial also required the prestent angioplasty to be submaximal (nominal diameter of the balloon to be 80% of the target artery). A comparison between submaximal and maximal (nominal diameter of the balloon to be 100% of the target artery) prior to Wingspan deployment demonstrated similar rates of major periprocedural neurological complications (9.0% overall) in one study 35 …”

“…A comparison between submaximal and maximal (nominal diameter of the balloon to be 100% of the target artery) prior to Wingspan deployment demonstrated similar rates of major periprocedural neurological complications (9.0% overall) in one study. 35 With the current technology, it appears unlikely that use of balloon-expanding stents or maximal prestent angioplasty would have resulted in a lower rate of stroke and/or death in the endovascularly treated patients in the trial.…”