Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

2021 ◽  
pp. neurintsurg-2021-018117
Author(s):  
Tengfei Zhou ◽  
Tianxiao Li ◽  
Liangfu Zhu ◽  
Zhaoshuo Li ◽  
Qiang Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Stent Retriever ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Thrombectomy Device ◽  
Symptomatic Intracranial Hemorrhage ◽  
Solitaire Fr ◽  
To Receive

BackgroundMechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS.MethodsThis study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation.ResultsA total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups.ConclusionEndovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

scholarly journals Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Huan Liu ◽  
Zhaoshuo Li ◽  
Liangfu Zhu ◽  
Tengfei Zhou ◽  
Qiaowei Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Stent Retriever ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
New Device ◽  
Thrombectomy Device ◽  
Solitaire Fr

Background: Stent retriever thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in anterior circulation. The aim of the trial is to evaluate whether the new thrombectomy device-Skyflow can achieve the same safety and efficacy as Solitaire FR in the treatment.Method: This study is a prospective, multicenter, stratified randomized, single blind, paralleled, positive controlled, non-inferiority clinical trial. The safety and efficacy of vascular recanalization in AIS patients who are treated with either a new thrombectomy device-Skyflow or with Solitaire FR and within 8 h of symptom onset will be compared. A total of 192 patients will be enrolled, each group with 96 patients. The primary endpoint is successful recanalization rate after the operation. The secondary efficacy endpoints are the time from artery puncture to successful recanalization (mTICI 2b-3), NIHSS scores of 24 h (18–36 h), and 7 ± 2 days after the operation, mRS scores, and the rate of patients with mRS 0–2 scores 90 ± 14 days after the operation, and the success rate of instrument operation. The safety endpoints are the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage at 24 h (18–36 h) post-operation, incidence of adverse events (AE) and serious adverse events (SAE), all-cause mortality, and incidence of device defects.Discussion: This trial will provide information on the safety and efficacy of Sky-flow stent retriever in the treatment of AIS patients with anterior circulation LVO. The success of this trial will be the basis for the product to be finally officially listed and applied in China.Trial registration: Registered on 11 March 2018 with Chinese clinical trial registry. Registration number is ChiCTR1800015166.

Abstract WP1: Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent-Retriever, Aspiration, MERCI: Multi-Center Experience

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kunakorn Atchaneeyasakul ◽  
Amer M Malik ◽  
Dileep R Yavagal ◽  
Mehdi Bouslama ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Middle Cerebral Artery ◽  
Acute Ischemic Stroke ◽  
Cerebral Artery ◽  
Tertiary Care ◽  
Stent Retriever ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Symptomatic Intracerebral Hemorrhage ◽  
Significant Difference

Introduction: Recent trials demonstrated that mechanical thrombectomy improve functional outcome in anterior circulation acute ischemic stroke (AIS) due to emergent large vessel occlusion (ELVO) of the middle cerebral artery (MCA) M1 segment. However, such data regarding AIS due to MCA M2 segment ELVO is limited. Analysis of the STAR, SWIFT, and SWIFT-PRIME trials found thrombectomy in MCA M2 occlusion to be feasible in achieving successful reperfusion. The most optimal technique and/or device used for such reperfusion is not clearly defined. We aim to compare the outcome for the contemporary techniques and devices used for thrombectomy of AIS patients due to MCA M2 ELVO. Methods: A retrospective review of AIS patients with MCA M2 ELVO receiving thrombectomy from three tertiary care academic medical centers was conducted. Thrombectomy technique and thrombectomy device utilized were recorded. Outcomes were successful angiographic reperfusion (TICI ≥2b), favorable modified Rankin Scale (mRS≤2) at discharge and at 90 days, and rate of symptomatic intracerebral hemorrhage (sICH). Results: From October 1999 through June 2016, 253 AIS patients underwent thrombectomy for MCA M2 ELVO. Thrombectomy methods utilized were Stent-retriever (n=118), Aspiration only [manual or Penumbra device] (n=83), and MERCI retriever (n=52). Table 1 shows rate of outcomes measured. There was no difference in baseline NIHSS or in stroke onset to groin puncture time. Stent-retriever group showed a significantly higher recanalization rate, lower sICH rate, and favorable 90-day mRS versus Aspiration group or MERCI group, respectively. No significant difference was seen in discharge mRS between the groups. Conclusions: Thrombectomy for AIS patients with MCA M2 ELVO with Stent-retriever appears to be feasible with a significantly higher rate of recanalization, lower sICH rate, and favorable 90-day mRS when compared to Aspiration and MERCI.

scholarly journals Outcome of endovascular treatment within and beyond 6 h without perfusion software

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Zhen Jing ◽  
Hao Li ◽  
Shengming Huang ◽  
Min Guan ◽  
Yongxin Li ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
General Anesthesia ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Symptom Onset ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Group A ◽  
Group B

AbstractEndovascular treatment (EVT) has been accepted as the standard of care for patients with acute ischemic stroke. The aim of the present study was to compare clinical outcomes of patients who received EVT within and beyond 6 h from symptom onset to groin puncture without perfusion software in Guangdong district, China. Between March 2017 and May 2018, acute ischemic stroke patients who received EVT from 6 comprehensive stroke centers, were enrolled into the registry study. In this subgroup study, we included all patients who had acute proximal large vessel occlusion in the anterior circulation. The demographic, clinical and neuroimaging data were collected from each center. A total of 192 patients were included in this subgroup study. They were divided into two groups: group A (n = 125), within 6 h; group B (n = 67), 6–24 h from symptom onset to groin puncture. There were no substantial differences between these two groups in terms of 90 days favorable outcome (modified Rankin scale [mRS] ≤ 2, P = 0.051) and mortality (P = 0.083), and the risk of symptomatic intracranial hemorrhage at 24 h (P = 0.425). The NIHSS (median 16, IQR12-20, group A; median 12, IQR8-18, group B; P = 0.009) and ASPECTS (median 10, IQR8-10, group A; median 9, IQR8-10, group B; P = 0.034) at baseline were higher in group A. The anesthesia method (general anesthesia, 21.3%, group A vs. 1.5% group B, P = 0.001) were also statistically different between the two groups. The NIHSS and ASPECTS were higher, and general anesthesia was also more widely used in group A. Clinical outcomes were not significantly different within 6 h versus 6–24 h from symptom onset to groin puncture in this real world study.

Predictors of parenchymal hemorrhage after endovascular treatment in acute ischemic stroke: data from ANGEL-ACT Registry

2022 ◽  
pp. neurintsurg-2021-018292
Author(s):  
Dapeng Sun ◽  
Baixue Jia ◽  
Xu Tong ◽  
Peter Kan ◽  
Xiaochuan Huo ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Multivariable Analysis ◽  
Serum Glucose ◽  
Chinese Patients ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Atherosclerotic Stenosis

BackgroundParenchymal hemorrhage (PH) is a troublesome complication after endovascular treatment (EVT).ObjectiveTo investigate the incidence, independent predictors, and clinical impact of PH after EVT in patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO).MethodsSubjects were selected from the ANGEL-ACT Registry. PH was diagnosed according to the European Collaborative Acute Stroke Study classification. Logistic regression analyses were performed to determine the independent predictors of PH, as well as the association between PH and 90-day functional outcome assessed by modified Rankin Scale (mRS) score.ResultsOf the 1227 enrolled patients, 147 (12.0%) were diagnosed with PH within 12–36 hours after EVT. On multivariable analysis, low admission Alberta Stroke Program Early CT score (ASPECTS)(adjusted OR (aOR)=1.13, 95% CI 1.02 to 1.26, p=0.020), serum glucose >7 mmol/L (aOR=1.82, 95% CI 1.16 to 2.84, p=0.009), and neutrophil-to-lymphocyte ratio (NLR; aOR=1.05, 95% CI 1.02 to 1.09, p=0.005) were associated with a high risk of PH, while underlying intracranial atherosclerotic stenosis (ICAS; aOR=0.42, 95% CI 0.22 to 0.81, p=0.009) and intracranial angioplasty/stenting (aOR=0.37, 95% CI 0.15 to 0.93, p=0.035) were associated with a low risk of PH. Furthermore, patients with PH were associated with a shift towards to worse functional outcome (mRS score 4 vs 3, adjusted common OR (acOR)=2.27, 95% CI 1.53 to 3.38, p<0.001).ConclusionsIn Chinese patients with AIS caused by anterior circulation LVO, the risk of PH was positively associated with low admission ASPECTS, serum glucose >7 mmol/L, and NLR, but negatively related to underlying ICAS and intracranial angioplasty/stenting.Trial registration numberNCT03370939.

Abstract WP39: Mechanical Embolectomy for Acute Ischemic Stroke Beyond Six Hours From Symptom Onset Using Advanced MR Imaging

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ryan McTaggart ◽  
Shadi Yaghi ◽  
Daniel C Sacchetti ◽  
Richard Haas ◽  
Shawna Cutting ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Mr Imaging ◽  
Acute Ischemic Stroke ◽  
Large Vessel ◽  
Lesion Volume ◽  
Large Artery ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome

Background: There is very limited data on the use of advanced neuroimaging to select patients with acute ischemic stroke and large vessel occlusion for intraarterial therapy beyond 6 hours from onset. Our aim is to report the outcome of patients with acute ischemic stroke and large artery occlusion who presented beyond 6 hours from onset, had favorable MRI imaging profile, and underwent mechanical embolectomy. Methods: This is a single institution retrospective study between December 1st, 2015, and July 30 th , 2016 with acute ischemic stroke and anterior circulation large vessel occlusion (LVO) with ASPECTS of 6 or more and beyond 6 hours from symptoms onset. Favorable imaging profile was defined as 1) DWI lesion volume (as defined as apparent diffusion coefficient < 620 X 10-6 mm2/s) of 70 mL or less AND 2) Penumbra volume (as defined by volume of tissue with Tmax >6 sec) of 15 mL or greater AND 3) A mismatch ratio of 1.8 or more AND 4) Volume of tissue with perfusion lesion with Tmax > 10 sec is less than 100 mL. Good outcome was defined as a 90 day mRS≤2. Results: In the study period, 41 patients met the inclusion criteria; 22 (53.6%) had favorable imaging profile and underwent mechanical embolectomy. The median age was 75 years (59-92), 68.2% were females; the median time from last known normal to groin puncture was 684.5 minutes (range 363-1628) and the median admission NIHSS score was 17.5 (range 4-28). The rate of good outcomes in this series was similar to that in a patient level pooled meta-analysis of the recent endovascular trials (68.2% vs. 46.0%, p=0.07). The rate of good outcome matches that of the EXTEND-IA trial that selected patients using perfusion imaging (68.2% vs. 71.0%, p = 1.00). None of the patients in our cohort had symptomatic intracereberal hemorrhage. Conclusion: Advanced MR imaging may help select patients with acute ischemic stroke and anterior circulation large vessel occlusion for embolectomy beyond the treatment window used in most endovascular trials.

Abstract TP43: Is Unintended Hypothermia After Endovascular Therapy Associated With Improved Functional Outcome of Patients With Acute Ischemic Stroke?

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Christian Hartmann ◽  
Simon Winzer ◽  
Timo Siepmann ◽  
Lars-Peder Pallesen ◽  
Alexandra Prakapenia ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Venous Thromboembolism ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Endovascular Therapy ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome ◽  
Risk Ratios

Introduction: Hypothermia may be neuroprotective in acute ischemic stroke. Stroke patients with anterior circulation large vessel occlusion (acLVO) who receive endovascular therapy (EVT) are frequently hypothermic after the procedure. We sought to analyze whether this unintended hypothermia was associated with improved functional outcome. Methods: We extracted data of consecutive patients (01/2016-04/2019) from our prospective EVT database that includes all patients screened for EVT at our center. We included patients with acLVO who received EVT and analyzed recanalization (mTICI 2b-3) and complications (i.e., pneumonia, bradyarrhythmia, venous thromboembolism) during the hospital course. We assessed functional outcome at 3 months and analyzed risk ratios (RR) for good outcome (mRS scores 0-2) and mortality of patients who were hypothermic (<36°C) compared to patients who were normothermic ( > 36°C) after EVT. We compared the frequency of complications and calculated RRs for good outcome and mortality in the subgroup with recanalization. Results: Among 674 patients with anterior circulation ischemic stroke, 372 patients received EVT for acLVO (178 [47%] male, age 77 years [65-82], NIHSS score 16 [12 - 20]). Of these, 186 patients (50%) were hypothermic (median [IQR] temperature 35.2°C [34.7-35.6]) and 186 patients were normothermic (media temperature 36.4 [36.2-36.8]) after EVT. At 3 months, 54 of 186 (29.0%) hypothermic patients compared with 65 of 186 (35.0%) normothermic patients had a good outcome (RR, 0.83; 95%CI 0.62-1.12) and 52 of 186 (27.9%) hypothermic patients compared with 46 of 186 (24.7%) normothermic patients had died (RR, 1.13; 95%CI 0.8-1.59). This relation was consistent in 307 patients (82.5% of all EVTs) with successful recanalization (good outcome: RR, 0.85; 95%CI 0.63-1.14.; mortality: RR, 1.05; 95%CI 0.7-1.57). More hypothermic patients suffered pneumonia (37.8% vs. 24.7%; p=0.003) or bradyarrhythmia (55.6% vs. 18.3%; p<0.001). Venous thromboembolism was distributed similarly (5.4% vs. 6.5%; p=0.42). Conclusion: Unintended hypothermia following EVT for acLVO was not associated with improved functional outcome or reduced mortality but an increased complication rate in patients with acute ischemic stroke.

Abstract TP18: Endovascular Treatment in the Elderly with Acute Ischemic Stroke - Is it Safe in Clinical Practice?

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Thabele M Leslie-Mazwi ◽  
Syed F Ali ◽  
Sanjeeva R Onteddu ◽  
Adewumi D Amole ◽  
Mehmet S Akdol ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Hospital Mortality ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Univariate Analysis ◽  
The Elderly ◽  
Stroke Patients ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Younger Patients

Introduction: An overwhelming benefit from endovascular treatment (EVT) of acute ischemic stroke (AIS) has been shown in recent trials, making it the new evidence-based standard of care for ischemic stroke due to anterior circulation large vessel occlusion. We sought to determine usage, safety and efficacy of EVT in patients ≥80 years of age. Methods: Using GWTG stroke registry data from MGH and UAMS, we analyzed 7,505 consecutive stroke admissions from 01/2009 - 06/2016. Univariate analysis was carried out to compare AIS patients < 80 vs. those ≥ 80yr. Results: Of the total 7,505 AIS patients, 3,722 presented within 12 hr of last known well and of these 334 (334/3722, 9%) underwent EVT. The majority of AIS patients undergoing EVT were younger than 80yr of age (264/334, 79%). Of the patients who underwent EVT, younger patients were more often male, Caucasian, and had stroke risk factors of atrial fibrillation, CAD, hypertension and smokers. The two groups were similar in NIHSS, initial clinical presentation, modified pre-stroke Rankin scale of ≤ 3, and initiation of tPA as a drip and ship or stroke center front-door administration. Higher rates of pneumonia were observed in younger patients while rates of sICH were similar. Younger patients were more often discharged to home/inpatient rehabilitation facility. On univariate analysis, in-hospital mortality was significantly higher in patients ≥ 80yr [Unadj. OR 2.50 (1.24, 5.03), p=0.01], however the strength of the association attenuated substantially after adjusting for significant covariates [Adj. OR 2.34 (0.99, 5.47), p=0.05] (Table). Conclusion: Elderly stroke patients are largely excluded from clinical trials and data are limited on the effectiveness of EVT in this cohort. Our results showed that rate of sICH and adjusted in-hospital mortality was not statistically different between those < 80yr vs. ≥ 80yr. Further studies are needed to explore the functional outcome of the elderly stroke patients undergoing EVT.

scholarly journals Workflow Intervals of Endovascular Acute Stroke Therapy During On- Versus Off-Hours

Stroke ◽  
2019 ◽  
Vol 50 (10) ◽  
pp. 2842-2850 ◽  
Author(s):  
Wouter H. Hinsenveld ◽  
Inger R. de Ridder ◽  
Robert J. van Oostenbrugge ◽  
Jan A. Vos ◽  
Adrien E. Groot ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Large Vessel ◽  
Complication Rates ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Significant Difference

Background and Purpose— Endovascular treatment (EVT) of patients with acute ischemic stroke because of large vessel occlusion involves complicated logistics, which may cause a delay in treatment initiation during off-hours. This might lead to a worse functional outcome. We compared workflow intervals between endovascular treatment–treated patients presenting during off- and on-hours. Methods— We retrospectively analyzed data from the MR CLEAN Registry, a prospective, multicenter, observational study in the Netherlands and included patients with an anterior circulation large vessel occlusion who presented between March 2014 and June 2016. Off-hours were defined as presentation on Monday to Friday between 17:00 and 08:00 hours, weekends (Friday 17:00 to Monday 8:00) and national holidays. Primary end point was first door to groin time. Secondary end points were functional outcome at 90 days (modified Rankin Scale) and workflow time intervals. We stratified for transfer status, adjusted for prognostic factors, and used linear and ordinal regression models. Results— We included 1488 patients of which 936 (62.9%) presented during off-hours. Median first door to groin time was 140 minutes (95% CI, 110–182) during off-hours and 121 minutes (95% CI, 85–157) during on-hours. Adjusted first door to groin time was 14.6 minutes (95% CI, 9.3–20.0) longer during off-hours. Door to needle times for intravenous therapy were slightly longer (3.5 minutes, 95% CI, 0.7–6.3) during off-hours. Groin puncture to reperfusion times did not differ between groups. For transferred patients, the delay within the intervention center was 5.0 minutes (95% CI, 0.5–9.6) longer. There was no significant difference in functional outcome between patients presenting during off- and on-hours (adjusted odds ratio, 0.92; 95% CI, 0.74–1.14). Reperfusion rates and complication rates were similar. Conclusions— Presentation during off-hours is associated with a slight delay in start of endovascular treatment in patients with acute ischemic stroke. This treatment delay did not translate into worse functional outcome or increased complication rates.

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