Evaluation of acute mechanical revascularization in large stroke (ASPECTS ⩽5) and large vessel occlusion within 7 h of last-seen-well: The LASTE multicenter, randomized, clinical trial protocol.

RATIONALE: Mechanical thrombectomy (MT), the standard of care for acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO), is generally not offered to patients with large baseline infarct (core). Recent studies demonstrated MT benefit in patients with anterior circulation stroke and large core (i.e. Alberta Stroke Program Early Computed Tomography Score, ASPECTS 3-5). However, its benefit in patients with the largest core (ASPECTS 0-2) remains unproven. AIM: To compare the efficacy and safety of MT plus best medical treatment (BMT) and of BMT alone in patients with ASPECTS 0-5 (baseline computed tomography (CT) or magnetic resonance imaging (MRI)) and anterior circulation LVO within 7 h of last-seen-well. SAMPLE SIZE ESTIMATE: To detect with a two-sided test at 5% significance level (80% power) a common odds ratio of 1.65 for 1-point reduction in the 90-day modified Rankin Scale (mRS) score in the MT + BMT arm versus BMT arm and to anticipate 10% of patients with missing primary endpoint, 450 patients are planned to be included by 36 centers in France, Spain, and the United States. METHODS AND DESIGN: LArge Stroke Therapy Evaluation (LASTE) is an international, multicenter, Prospectively Randomized into two parallel (1:1) arms, Open-label, with Blinded Endpoint (PROBE design) trial. Eligibility criteria are diagnosis of AIS within 6.5 h of last-seen-well (or negative fluid-attenuated inversion recovery (FLAIR) if unknown stroke onset time), ASPECTS 0-5 (ASPECTS 4-5 for ⩾80-year-old patients), and LVO in the anterior circulation (intracranial internal carotid artery (ICA) and M1 or M1-M2 segment of the middle cerebral artery (MCA)). STUDY OUTCOMES: The primary endpoint is the day-90 mRS score distribution (shift analysis) with mRS categories 5 and 6 coalesced into one category. Secondary endpoints include day-180 mRS score, rates of 90-day and 180-day mRS score = 0-2 and 0-3, rate of decompressive craniectomy, the National Institutes of Health Stroke Scale (NIHSS) score change, revascularization and infarct volume growth at 24 h, and quality of life at day 90 and 180. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and early NIHSS score worsening) are recorded. A dynamic balanced randomization (1:1) is used to distribute eligible patients into the experimental arm and control arm, by incorporating the center and these pre-specified factors: baseline ASPECTS (0-3 vs 4-5), age (⩽70 vs >70 years), baseline NIHSS (<20 vs ⩾20), intravenous thrombolysis (no vs yes), admission mode (Drip-and-Ship vs Mothership), occlusion site (intracranial ICA vs MCA-M1 or M1-M2), intravenous fibrinolysis (no vs yes), and last-seen-well to randomization time (0-4.5 vs >4.5-6.5 h). DISCUSSION: The LASTE trial will determine MT efficacy and safety in patients with ASPECTS 0-5 and LVO in the anterior circulation. TRIAL REGISTRATION: LASTE Trial NCT03811769.

Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol.

RATIONALE: Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients with National Institutes of Health Stroke Scale (NIHSS) score ⩽ 5 is unproven. AIM: To demonstrate the superiority of immediate MT plus best medical treatment (BMT) compared to BMT (with secondary MT in case of deterioration) for increasing the rate of modified Rankin Scale (mRS) score ⩽ 1 at 90 days after minor stroke (NIHSS score ⩽ 5) and anterior circulation LVO. SAMPLE SIZE ESTIMATES: To detect an absolute increase of 10% (80% power) in the 90-day mRS score = 0-1 rate in the MT + BMT group, by assuming an mRS score = 0-1 rate of 60% in the BMT group and by considering two interim efficacy/futility analyses (after study completion by 274 and 548 patients), 824 patients must be included by 36 centers in France, Spain, and the USA. METHODS AND DESIGN: MOSTE is an international, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint trial. Eligibility criteria are diagnosis of acute ischemic stroke within 23 h of last-seen-well, NIHSS score ⩽ 5, and LVO in the anterior circulation (intracranial internal carotid artery, M1 or M1-M2 segment of the middle cerebral artery). STUDY OUTCOMES: The primary endpoint is the rate of excellent outcome at day 90 (mRS score = 0-1). Secondary endpoints include the rates of 90-day mRS score = 0-2 and score = 0, NIHSS score change, secondary MT, revascularization and infarct volume growth at 24 h, and quality of life and cognitive function at day 90. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and rapid NIHSS score worsening) are recorded. DISCUSSION: The MOSTE trial will determine MT efficacy and safety in patients with minor stroke and LVO in the anterior circulation. TRIAL REGISTRATION: MOSTE Trial. NCT03796468.

PC400 volumetric coils minimize radiation, reduce procedure time and optimize packing density during endovascular treatment in medium sized cerebral aneurysms.

BACKGROUND AND OBJECTIVES: The Penumbra Coil 400 (PC400) is designed to improve endovascular filling for intracranial aneurysms. The aim of this retrospective, single-operator study was to compare the use of the PC400 with conventional 0.010inch coils in procedure time, X-ray exposure and packing density. METHODS: We collected data from 31patients with 6 to 10mm diameter aneurysms embolized using the PC400, from May 2012 to November 2013. This group was compared with a control group of 27patients treated with conventional 0.010inch coils by the same operator. In both groups, clinical events, number of coils used, duration and cost of procedure, time of fluoroscopy and packing density were studied. RESULTS: No serious adverse events were found in either group. Asymptomatic prolapse of coil loop into the parent artery were noted in two patients. Number of coils used was 4.45/6.35 in PC400 and control groups, respectively. Duration of procedure was 29.8/49.2minutes respectively (P-value=0.0002), and time of fluoroscopy was 28/41minutes (P-value=0.0109). Total radiation was 6098/6876cGy.cm(2) respectively. Comparison of packing densities after the first coil showed respectively 22.7%/10.6%, and after the final imaging, 53%/28.5% (P-values<0.0001). Complete or near complete occlusion on follow-up at 3months was 100% for PC400 versus 92% in the control group. Using 0.010inch coils may result in a 56% increase in treatment cost. CONCLUSION: PC400 coils save procedural time and time of fluoroscopy, are cost saving and allow dramatic improvement of packing density on final imaging.