Icad stroke
These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis. Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58 24.1% ) vs the medical group (6/53 11.3% ) ( P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up.Ĭonclusions and Relevance Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58 36.2% ) vs the medical group (8/53 15.1% ) ( P = .02). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58 8.6% ) vs none in the medical group (95% CI, 0%-5.5%) ( P = .06). The 30-day primary safety end point occurred in more patients in the stent group (14/58 24.1% ) vs the medical group (5/53 9.4% ) ( P = .05).
Icad stroke trial#
Results Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Main Outcomes and Measures Primary outcome measure: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization.
Icad stroke plus#
Interventions Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group n = 59) or medical therapy alone (medical group n = 53). Objective To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%).ĭesign, Setting, and Patients VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. Importance Intracranial stenosis is one of the most common etiologies of stroke.