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

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.

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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

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-018117 ◽

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%).

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

Stroke ◽

10.1161/str.48.suppl_1.wp1 ◽

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.

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North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2013-010895.rep ◽

2018 ◽

Vol 10 (Suppl 1) ◽

pp. i45-i49 ◽

Cited By ~ 1

Author(s):

Osama O Zaidat ◽

Alicia C Castonguay ◽

Rishi Gupta ◽

Chung-Huan J Sun ◽

Coleman Martin ◽

...

Keyword(s):

Ischemic Stroke ◽

Clinical Practice ◽

Clinical Outcome ◽

Acute Stroke ◽

Acute Ischemic Stroke ◽

North American ◽

Outcome Data ◽

Stent Retriever ◽

Post Marketing ◽

Solitaire Fr

BackgroundLimited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials.MethodsThe investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage.Results354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2).ConclusionsThe NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

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Real-world stent retriever thrombectomy for acute ischemic stroke beyond 6 hours of onset: analysis of the NASA and TRACK registries

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014272 ◽

2018 ◽

Vol 11 (4) ◽

pp. 334-337 ◽

Cited By ~ 10

Author(s):

Maxim Mokin ◽

Alex Abou-Chebl ◽

Alicia C Castonguay ◽

Raul G Nogueira ◽

Joey D English ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Stroke ◽

Acute Ischemic Stroke ◽

Real World ◽

Symptom Onset ◽

Individual Patient Data ◽

Patient Data ◽

Stent Retriever ◽

Anterior Circulation ◽

Stroke Symptom

BackgroundThe DEFUSE 3 and DAWN trials have shown the benefit of thrombectomy beyond 6 hours of stroke symptom onset in carefully selected patients.ObjectiveTo evaluate the real-world outcomes of stent retriever thrombectomy beyond 6 hours of stroke onset using combined individual patient data from the North American Solitaire Stent Retriever Acute Stroke (NASA) and Trevo Stent-Retriever Acute Stroke (TRACK) registries.MethodsPooled analysis of individual patient data of all cases of anterior circulation acute ischemic stroke (AIS) from NASA and TRACK was performed to compare outcomes of patients presenting within the first hours 6 or beyond 6 hours of stroke symptom onset.ResultsOf 830 patients with anterior circulation AIS from the NASA and TRACK registries, 32.7% (271 patients) underwent thrombectomy beyond the first 6 hours of symptom onset. The rates of good clinical outcome (modified Rankin scale score of 0–2 at 90 days), mortality, and symptomatic intracranial hemorrhage were similar: 48.1%, 20.6%, and 8.0% within 0–6 hours, 46.2%, 21.6%, and 10.9% within 6–16 hours, and 38.9%, 33.3%, and 5% within 16–24 hours (p=0.8, 0.6, and 0.5, respectively). The rates of successful recanalization (Thrombolysis in Cerebral Infarction 2b/3) were 79.4% in patients with stroke within 0–6 hours, 72.6% within 6–16 hours, and 85.0% within 16–24 hours (p=0.04).ConclusionsReal-world experience with patients with anterior circulation AIS treated with the Solitaire and Trevo thrombectomy devices beyond the first 6 hours of symptom onset proved to be equally safe and effective as for patients with symptom onset within the first 6 hours.

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Thrombectomy of calcified emboli in stroke. Does histology of thrombi influence the effectiveness of thrombectomy?

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013226 ◽

2017 ◽

Vol 10 (4) ◽

pp. 345-350 ◽

Cited By ~ 32

Author(s):

Tomas Dobrocky ◽

Eike Piechowiak ◽

Alessandro Cianfoni ◽

Felix Zibold ◽

Luca Roccatagliata ◽

...

Keyword(s):

Mechanical Properties ◽

Ischemic Stroke ◽

Clinical Practice ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Endovascular Therapy ◽

Stent Retriever ◽

Complication Rates ◽

Peripheral Vessel ◽

Stent Retrievers

Background and purposeThrombus composition has been postulated to affect the success of endovascular therapy. Calcified clots are composed of large amounts of calcium phosphate which influences their mechanical properties and may serve as a model for testing this hypothesis. The aim of this study was to evaluate the recanalization and complication rates of calcified thromboemboli in patients with acute ischemic stroke who underwent thrombectomy.Material and methodsA retrospective analysis was performed of all calcified intracranial thromboemboli in patients suffering an acute ischemic stroke, referred for endovascular therapy at two centers between January 2013 and July 2016.ResultsEight patients with a calcified intracranial clot underwent stent retriever thrombectomy (five women; mean age 80 years). Mean clot attenuation was 305 HU (range 150–640 HU). Successful reperfusion defined, as Thrombolysis in Cerebral Infarction grade 2b–3 was achieved in only one patient (12.5%). Two periprocedural adverse events occurred: one peripheral vessel perforation which was coiled and one inadvertent stent retriever detachment due to fracture of the stent retriever wire.ConclusionStent retriever thrombectomy of calcified thromboemboli seems less effective than with other types of clots. Different mechanical properties of calcified clots may render them stiffer and less accessible for stent retrievers. When faced with a calcified intracranial thromboembolus in clinical practice, a more contained approach may be warranted in view of low recanalization rates, and the potential for periprocedural adverse events.

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TCT-68 Safety and efficacy of stent retriever for the management of acute ischemic stroke. Comprehensive review and meta-analysis

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2015.08.845 ◽

2015 ◽

Vol 66 (15) ◽

pp. B30-B31

Author(s):

Konstantinos Marmagkiolis ◽

Abdul Hakeem ◽

Mehmet Cilingiroglu ◽

Cezar Iliescu ◽

Despina Tsitlakidou ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Meta Analysis ◽

Stent Retriever ◽

Safety And Efficacy ◽

Comprehensive Review

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Abstract P530: Safety of Intravenous Cangrelor in Acute Ischemic Stroke

Stroke ◽

10.1161/str.52.suppl_1.p530 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Hisham Salahuddin ◽

Giana Dawod ◽

Syed F Zaidi ◽

Mouhammad A Jumaa

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Antiplatelet Therapy ◽

Functional Outcomes ◽

Retrospective Case ◽

Severe Stenosis ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Baseline Characteristics ◽

Control Study

Introduction: Mechanical Thrombectomy often requires immediate antiplatelet therapy when emergent stenting is needed. Intravenous cangrelor (CGR) is a potent reversible intravenous antiplatelet with a fast onset, a short half-life, and predictable pharmacokinetics. We sought to evaluate the safety and efficacy of this drug in MT patients. Methods: We performed a retrospective case control study at a CSC between 3/2016 and 4/2020. Patients who received intravenous CGR within 6 hours of admission (between 10/2019 - 4/2020) were compared with patients with anterior circulation tandem MCA occlusions who required stenting and oral antiplatelet therapy (between 3/16 - 10/19), prior to the availability of CGR at our facility. Results: We identified 35 patients, 12 of whom received IV CGR and 23 received acute oral antiplatelets for tandem occlusions. Average age of the cohort was 68.5 ± 13.4. Baseline characteristics including co-morbidities, rate of IV tPA, and time metrics were similar between the two groups. In the CGR group, nine patients had tandem anterior circulation occlusions, two had basilar occlusions, and one patient had an MCA occlusion secondary to severe stenosis. Eleven of the twelve patients in the CGR group required acute stenting. Intravenous CGR was used for an average of 20.2 hours after which patients were transitioned to aspirin and ticagrelor (33%) or clopidogrel (67%). Successful recanalization was achieved in all patients who received IV-CGR and in 95.7% of the tandem group. Final infarct volumes were comparable between the CGR and tandem cohorts (7.1 vs 15.5 ml; p=0.75). There were two cases of asymptomatic hemorrhage in both the CGR group and the tandem cohort, and one case of symptomatic ICH in the tandem cohort. Final functional outcomes (83.3% vs 60.9%; p=0.259) and mortality at three months (13% vs. 17%; p=1) were similar between the two groups. Conclusions: IV CGR is a promising medication for patients with acute ischemic stroke who require an immediate antiplatelet effect and is comparable in safety and efficacy to oral antiplatelets in the acute period of ischemic stroke. Larger prospective studies on the efficacy and safety of CGR in neurointervention are warranted.

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Abstract 75: A Retrospective Multicenter Study of Solitaire™ FR for Revascularization in the Treatment of Acute Ischemic Stroke

Stroke ◽

10.1161/str.43.suppl_1.a75 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Antoni Dávalos ◽

Jan Gralla ◽

Alain Bonafé ◽

René Chapot ◽

Tommy Andersson ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Rescue Therapy ◽

Artery Occlusion ◽

Large Artery ◽

Safety And Efficacy ◽

Score Improvement ◽

First Choice ◽

Device Use ◽

Solitaire Fr

Background & purpose: To evaluate safety and efficacy of the Solitaire FR in the treatment of patients with acute ischemic stroke (AIS) secondary to large artery occlusion. Methods: Retrospective study of consecutive patients presenting with AIS treated with Solitaire FR as the first choice device to restore blood flow in 6 experienced European sites according to the hospitals’ stroke protocols (direct IA, bridging IV t-PA/IA and failed or contraindicated IV t-PA). Sites provided patient information at pre-procedure, procedure, 24hrs, discharge and 90 days. An independent Core Lab evaluated TICI scores on the pre-procedure and post-procedure angiograms. Recanalization was defined as TICI 2 or 3 post Solitaire FR device use and prior to any rescue therapy. Baseline and post-treatment brain CT or MRI were also centrally reviewed for symptomatic ICH classification (PH2 + death or neurologic deterioration). Good early neurological outcome was defined as NIHSS score improvement of ≥10 points or NIHSS 0,1 at discharge, and favourable functional outcome as modified Rankin Scale (mRS) score ≤ 2 at day 90. Patients with missing mRS data were judged to have worst possible outcome for data analysis. Results: Of the 206 patients treated with Solitaire FR, the device was used as first line treatment in 141 patients (mean age, 66; median NIHSS, 18): 74 patients were treated with IV t-PA prior to endovascular treatment, 56 had contra indication to IV t-PA and 11 were directly treated IA. Safety and efficacy results in the overall and IV t-PA treated patients are shown in the table . The mean number of recoveries was 1.8 and median time from groin puncture to successful revascularization was 45 minutes. Conclusions: This retrospective, uncontrolled study shows that Solitaire FR is safe and achieves good revascularization rates and functional outcomes in patients with AIS and large artery occlusion.

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Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention

JAMA Neurology ◽

10.1001/jamaneurol.2017.3967 ◽

2018 ◽

Vol 75 (3) ◽

pp. 304 ◽

Cited By ~ 28

Author(s):

Raul G. Nogueira ◽

Donald Frei ◽

Jawad F. Kirmani ◽

Osama Zaidat ◽

Demetrius Lopes ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Stent Retriever ◽

Safety And Efficacy ◽

3 Dimensional

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Intra-arterial Thrombectomy with Stent Retriever for Acute Ischemic Stroke – a Retrospective, Single-centered Study from Brazil

Arquivos Brasileiros de Neurocirurgia Brazilian Neurosurgery ◽

10.1055/s-0037-1607062 ◽

2017 ◽

Vol 36 (04) ◽

pp. 213-216

Author(s):

Luana Gatto ◽

Viviane Zétola ◽

Zeferino Demartini Junior ◽

Fábio Nascimento ◽

Gelson Koppe

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Mean Value ◽

Posterior Circulation ◽

Stent Retriever ◽

National Institutes Of Health ◽

Initial Experience ◽

Modified Rankin Scale ◽

Anterior Circulation ◽

The Mean

Objective To report our initial experience with intra-arterial thrombectomy (IAT) with stent retriever for acute ischemic stroke. Methods We conducted a retrospective review of patients with acute ischemic stroke who underwent IAT from September 2010 to August 2016. Results Forty-one patients were included; mean age was 57 years (range: 29–85), and 54% were women. There were 32 anterior circulation occlusions, and 11 posterior circulation occlusions. The mean value of the National Institutes of Health Stroke Scale (NIHSS) upon admission (available in 9/41 patients) was 14 (range: 6–20). Nineteen patients had favorable outcomes (modified Rankin Scale [mRS]: 0–2 at 6 months), and 22 had unfavorable outcomes (mRS: 3–6 at 6 months). The mortality rate was 37% (15/41). Favorable outcomes were associated with revascularization within the first 360 minutes of the onset of symptoms (p = 0.000001), and satisfactory revascularization (thrombolysis in cerebral infarction [TICI] scale: 2b or 3) (p = 0.0018). Conclusion It is of paramount importance to educate stroke teams on the benefits of IAT for acute ischemic stroke and the population on identifying stroke and seeking immediate care following symptom onset.

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