mTICI 2b-3 Research Articles

The safety and effectiveness of endovascular treatment for patients with vertebrobasilar artery occlusions: according to the BEST and BASICS criteria.

Background:Whether endovascular treatment (EVT) is safe and effective for vertebrobasilar artery occlusion (VBAO) is yet incompletely understood. Two RCTs, the endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST) trail and the Basilar Artery International Cooperation Study (BASICS), concentrating on this field were recently reported.Objective:We use real-world registry data of VBAO to compare the outcome of EVT inside and outside the inclusion and exclusion criteria of the BEST and BASICS study to testify the feasibility of the selection paradigms of VBAO in these trials.Methods:Consecutive patients with VBAO receiving EVT involving 21 stroke centers were retrospectively included. The safety outcomes [3-month mortality, symptomatic intracranial hemorrhage (sICH), and effectiveness outcomes (the proportion of 3-month functional independence (mRS of 0–2) and favorable outcome (mRS of 0–3)] were compared between VBAO patients who meet or failed to meet the BEST/BASICS selection criteria for EVT.Results:Our study cohort consisted of 577 VBAO patients who underwent EVT. Of them, 446 patients had pc-ASPECTS ≧8. Successful reperfusion (mTICI 2b or 3) was achieved in 85.4% (n = 493). There were 418 patients fulfilling the BEST criterion for EVT and 194 fulfilling the BASICS criterion. Regression analysis indicated that adherence to BEST or BASICS criterion for EVT was not independently related to most of the safety and effectiveness outcome except that adherence to BEST was significantly associated with the 3-month favorable outcome (ORBEST: 1.742, 95% CI: 1.087–2.790). However, when we put pc-ASPECTS into both criteria with a cut-off value of 8, meeting both BEST criterion plus pc-ASPECTS and BASICS criterion plus pc-ASPECTS was independently related to 3-month functional independence (ORBEST: 1.687, 95% CI: 1.077–2.644; ORBASIC: 1.653, 95% CI: 1.038–2.631) and favorable outcome (ORBEST: 2.280, 95% CI: 1.484–3.502; ORBASIC: 2.153, 95% CI: 1.372–3.378).Conclusion:Our study indicated that, based on real-world data of EVT, adherence to BEST or BASICS criterion for EVT was not independently associated with the safety and effectiveness outcome except that adherence to BEST was significantly related to the 3-month favorable outcome. However, the BEST or BASICS selection criterion and pc-ASPECTS ≧8 might be better paradigms for EVT patient selection.

Clinical Impact of Large Vessel Occlusion Achieved First Pass Effect with Stent Retriever Alone: A Single-Center Retrospective Analysis.

The first pass effect (FPE), which means the achievement of complete or near-complete reperfusion of large vessel occlusion (LVO) in the first pass, is one of the goals of mechanical thrombectomy (MT). However, the impact of FPE on the prognosis has not been assessed for Japanese patients with various degrees of independence before the onset of LVO. The purpose of this study was to investigate the prognostic effects of FPE in a comprehensive stroke center in Japan, which includes patients in a variety of self-independence states with different comorbidities before stroke onset. Between April 2017 and March 2020, 151 patients who underwent MT with a stent retriever (SR) alone as initial strategy for anterior circulation (internal carotid artery terminal, M1, M2) LVO at our hospital and finally achieved modified treatment in cerebral infarction (mTICI) 2b-3 were analyzed. Forty-eight patients in whom first pass mTICI 2c-3 was achieved were classified into the FPE+ group, and the other 103 patients were classified into the FPE- group. We compared the characteristics and clinical outcomes between patients with and without FPE, and estimated the odds ratio for outcomes after adjusting for confounders. The puncture-reperfusion time was shorter (20 vs. 35 minutes; p <0.01), and cardiogenic embolism was more common (81.3 vs. 60.2%; p = 0.01) in the FPE+ group. The FPE was significantly associated with good neurological outcome after 3 months (p <0.01; adjusted odds ratio [aOR], 3.87; 95% confidence interval [CI], 1.69-9.38), reduction in all intracranial hemorrhage (p <0.01; aOR, 0.24; 95% CI, 0.10-0.54), and symptomatic intracranial hemorrhage (p = 0.04; aOR, 0.16; 95% CI, 0.01-0.98). The FPE with an SR alone improved the neurological prognosis in a Japanese patient group.

Efficacy of Mechanical Thrombectomy Using an Aspiration Catheter Compared with a Stent Retriever Alone for Middle Cerebral Artery M2 Occlusion.

Mechanical thrombectomy (MT) for middle cerebral artery M2 occlusion (M2O) is challenging because the procedure is performed in a narrow and tortuous artery. In this study, we compared MT using an aspiration catheter (AC) versus a stent retriever (SR) used alone, and retrospectively evaluated the efficacy and safety of MT using an AC for M2O. Seventy-four consecutive patients who underwent MT for M2O at our institution between April 2016 and April 2020 were evaluated. The subjects were classified into those treated by AC (AC group) or SR alone (SR group). The AC group included patients treated by both contact aspiration and a combination technique of AC and SR. Background factors and outcomes, including modified treatment in cerebral infarction (mTICI) 2c-3 recanalization, were compared between the groups. AC and SR groups consisted of 47 and 27 patients respectively. Among them, the rate of mTICI 2b-3 was 93.6% vs 92.6%, and that of mTICI 2c-3 was 72.3% vs 48.2% (P = 0.004). The perioperative symptomatic subarachnoid hemorrhage (SAH) rate was 0% vs 7.4%, and modified Rankin scale scores of 0-2 were 78.6% vs 50% (P = 0.03). In the AC group, the mTICI 2c-3 rate was higher in patients in whom the AC was adequately advanced to the thrombus compared to those with inadequate AC advancement (83.3% vs 36.3%, P = 0.002). The rate of mTICI 2c-3 was higher in the AC than SR group, with no cases of symptomatic SAH. MT using AC for M2O might achieve safe and effective thrombectomy.

Effect of Intravenous Thrombolysis on Clot Survival during Mechanical Thrombectomy in Acute Large Vessel Occlusion Strokes.

The benefit of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT) in patients with large vessel occlusion (LVO) stroke is uncertain. Conventional metrics of final modified thrombolysis in cerebral ischemia (mTICI) score and 90-d modified Rankin Scale may be insensitive to IVT effects on procedural complexity and duration. To study the effect of IVT prior to MT on clot survival. We performed a single-center retrospective analysis of 257 acute stroke patients with LVO undergoing MT and analyzed the effect of IVT prior to MT using a novel, pass-by-pass clot survival methodology. The use of IVT was associated with a significantly lower number of passes to attain mTICI 2B or greater (P=.002) or mTICI 3 (P=.039) reperfusion. The number of patients who achieved mTICI 2B or greater after the first pass was significantly higher in the IVT group (P=.003). This increased rate of reperfusion persisted into subsequent passes. IVT prior to MT reduces the number of thrombectomy passes required to achieve mTICI 2B or mTICI 3 reperfusion. This information should be considered as the merits of IVT prior to MT are debated.

Identification of successful cerebral reperfusions (mTICI ≥2b) using an artificial intelligence strategy.

The modified thrombolysis in cerebral infarction (mTICI) scale is a widely used and validated qualitative tool to evaluate angiographic intracerebral inflow following endovascular thrombectomy (EVT). We validated a machine-learning (ML) algorithm to grade digital subtraction angiograms (DSA) using the mTICI scale. We included angiograms of identified middle cerebral artery (MCA) occlusions who underwent EVT. The complete DSA sequences were preprocessed and normalized. We created three convolutional neural networks to classify DSA into two outcomes, low- (mTICI 0,1,2a) and high-grade (mTICI 2b,2c,3). We included a total of 234 angiograms in this study. The area under the receiver operating characteristic was 0.863 (95% CI 0.816-0.909), 0.914 (95% CI 0.876-0.951), and 0.890 (95% CI 0.848-0.932) for the anteroposterior (AP), lateral (L), and combined models, respectively, when dichotomizing outcomes into low and high grade. The models' area under the precision-recall curve was 0.879 (95% CI 0.829-0.930), 0.906 (95% CI 0.844-0.968), and 0.887 (95% CI 0.834-0.941) for the AP, L, and combined models. In complete cerebral DSA, our angiography-based ML strategy was able to predict mTICI scores following EVT rapidly and reliably for MCA occlusions.

Endovascular Treatment for Acute Basilar Artery Occlusion: A Comparison of Arteriosclerotic, Embolic and Tandem Lesions.

To evaluate the safety and efficacy of endovascular treatment (EVT) for patients with acute ischemic stroke (AIS) due to intracranial atherosclerosis-related basilar artery occlusion (ICAS-related BAO) by comparison with embolic and tandem occlusion. We retrospectively reviewed consecutive patients with AIS due to BAO who underwent EVT. Patients were assigned to the ICAS-related group and embolic group, and tandem group based on the etiology. Baseline data, procedural details, and clinical outcomes were compared between the three groups. A total of 100 patients (ICAS-related group: 31; embolic group: 41; tandem group: 28) were included. No significant difference was observed in the successful reperfusion (mTICI 2b or 3), but the procedural time differed significantly (60min vs. 43min vs. 60min, P = 0.010). There were no differences in the different intracranial hemorrhage grades among the three groups (P = 0.134). After adjusting for baseline differences, there was no significant difference in pairwise comparisons regarding favorable outcome (mRS 0-2), moderate outcome (mRS 0-3), and mortality. Endovascular treatment for patients with acute ICAS-related BAO had equal efficacy and safety compared with embolic BAO and tandem BAO. Primary endovascular treatment and rescue modalities were effective treatments for acute ICAS-related BAO.

The Tigertriever 13 for mechanical thrombectomy in distal and medium intracranial vessel occlusions.

To report our two-center initial experience using the Tigertriever 13 in the treatment of acute stroke of distal, medium vessel occlusions (DMVO). We performed a retrospective analysis of all patients treated by mechanical thrombectomy using the Tigertriever 13 device (a manually expandable low profile stent retriever) due to an acute DMVO. Locations included the anterior, middle, and posterior cerebral artery in the A2 and A3, the M3 and M4, and the P2 or P3 segment and the superior cerebellar artery. Forty-three patients with 45 DMVOs underwent MTE using the Tigertriever 13 with the intention-to-treat approach between May 2019 and December 2020. After a median of two thrombectomy maneuvers, the successful recanalization rate (mTICI 2b-3) was 84.4% (38/45) with a first pass effect of 26.7% (12/45). The rate of symptomatic intracranial hemorrhages (sICH) and subarachnoid hemorrhages (SAH) was 7.0% (3/43) and 14.0% (6/43), respectively. At discharge, 53.5% (23/43) of the patients had a favorable clinical outcome (mRS 0-2). Mechanical thrombectomy in DMVOs using the Tigertriever 13 leads to high recanalization rates. The incidence of mostly asymptomatic hemorrhagic events appears higher compared to MTE procedures in LVOs. Further studies will help to identify anatomic and clinical criteria to define a guideline for MTE in DMVOs.

Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13).

PurposeTo evaluate the safety and efficacy of the Tigertriever 13 (Rapid Medical, Yoqneam, Israel) stent retriever in acute ischemic stroke (AIS) patients with primary or secondary distal, medium vessel occlusions (DMVO).MethodsWe performed a retrospective analysis of all consecutive AIS patients who underwent thrombectomy with the Tigertriever13 for DMVO. Patients’ characteristics were reviewed, procedural complications, angiographic (modified thrombolysis in cerebral infarction score [mTICI]) and clinical (modified Rankin Scale [mRS]) outcomes were documented.ResultsBetween November 2019 and November 2020, 16 patients with 17 DMVO were included (40% female, median age 60 [50–65] years). The Tigertriever13 was used in 11/17 (65%, median NIHSS of 8 [6–15]) primary DMVO and in 6/17 (35%, median NIHSS of 20 [13–24]) cases of secondary DMVO after a proximal thrombectomy. The successful reperfusion rate (mTICI 2b, 2c, 3) was 94% (16/17) for the dedicated vessel. At day 1, CT imaging showed a subarachnoid hemorrhage in 29% of the cases and a parenchymal hematoma in 12%. At 3 months, 65% of the patients (11/17) had a favorable outcome (mRS 0–2).ConclusionMechanical thrombectomy using the Tigertriever13 appears to be safe and effective for DMVO. Clinical and anatomical results are in line with those of patients with proximal occlusions.

First pass effect vs multiple passes complete reperfusion: A retrospective study.

First pass effect (FPE) is defined as achieving modified treatment in cerebral infarction (mTICI) grade 2c/3 reperfusion from the first pass and is associated with more favorable outcomes. We aimed to compare FPE and non-FPE using a large database and further compare first-pass mTICI 2b with multiple passes mTICI 3. A retrospective cohort study of acute ischemic stroke patients who received mechanical thrombectomy at a high-volume center was performed. Baseline characteristics and outcomes including rates of discharge and 90-day functional independence (modified Rankin Scale ≤2), mortality, symptomatic, and asymptomatic intracerebral hemorrhage were compared. Of the 637 patients included, 294 achieved FPE; 161 patients had multiple passes mTICI 3 and 36 had first pass mTICI 2b. Propensity-score matching resulted in 211 matched pairs for FPE vs non-FPE, and 30 matched pairs for multiple passes mTICI 3 vs first pass mTICI 2b. The FPE group had significantly more instances of discharge (33.6% vs 19.4%, p = 0.001) and 90-day functional independence (51.7% vs 40.8%, p = 0.032), and lower rates of mortality (18.0% vs 27.5%, p = 0.027) compared to non-FPE. There was no significant difference between first pass mTICI 2b and multiple passes mTICI 3 concerning any studied outcomes. First pass mTICI 2c/3 is safer and is associated with higher rates of functional independence. We did not observe a significant difference between first pass mTICI 2b and multiple passes mTICI 3. The limitations of this study prevent us from drawing conclusions related to the difference between them and calls for future large-scale studies to explore that further.

Mechanical Thrombectomy in Acute Terminal Internal Carotid Artery Occlusions Using a Large Manually Expandable Stentretriever (Tiger XL Device): Multicenter Initial Experience.

Background: The recently introduced Tigertriever XL Device for treatment of cerebral vessel occlusions combines manual adjustability and maximum length in one device. In this study, we report our initial experience with the Tigertriever XL in terminal ICA occlusions. Methods: Retrospective multicenter analysis of acute terminal ICA occlusions treated by mechanical thrombectomy using the Tigertriever XL Device. Results: 23 patients were treated using the Tigetriever XL due to an acute occlusion of the terminal ICA. The overall successful reperfusion rate after a median of two maneuvers using the Tigertriever XL Device was 78.3% (mTICI 2b-3). In 43.5% (10/23) additional smaller devices were applied to treat remaining occlusions in downstream territories, which resulted in a final successful reperfusion rate of 95.7%. Device related complications did not occur. Two symptomatic intracerebral hemorrhages (sICH) were observed. Conclusions: The Tigertriever XL Device might be a helpful tool in the treatment of ICA terminus occlusions with large clot burden resulting in high reperfusion rates. This is mainly related to the manual adjustability of the device combined with the maximum length.

Influence of prior intravenous thrombolysis on outcome after failed mechanical thrombectomy: ETIS registry analysis

BackgroundDespite constant improvements in recent years, sufficient reperfusion after mechanical thrombectomy (MT) is not reached in up to 15% of patients with large vessel occlusion stroke (LVOS). The outcome of...

Internal cerebral vein asymmetry is an independent predictor of poor functional outcome in endovascular thrombectomy

BackgroundEndovascular thrombectomy (EVT) in large vessel occlusion (LVO) in anterior circulation acute ischaemic stroke (AIS) results in good functional outcomes in only approximately 60% of the patients. Internal cerebral veins...

Histological composition behind CT-based thrombus density and perviousness in acute ischemic stroke

BackgroundClot composition could impact recanalization outcomes of thrombectomy, and preoperative imaging markers may help know about the histological components of thrombus. MethodsConsecutive patients who underwent thrombectomy from June 2017 to December 2019 were reviewed. The mean Hounsfield unit (HU) of thrombus (aHU) and contralateral artery (cHU) were recorded based on non-enhanced CT. The relative thrombus density was calculated (dHU=aHU-cHU). Hyperdense artery sign (HAS) was identified if dHU≥ 4HU. The clot perviousness was evaluated via thrombus attenuation increase (δHU) on contrast-enhanced CT compared to non-enhanced CT. Pervious clots were identified when δHU≥ 11HU. Tissue quantification for thrombus was based on Martius Scarlet Blue staining, using the Orbit Imaging Analysis Software. Spearman rank correlations was used to detect the association between imaging markers and clot composition. The differences in clinical characteristics were compared according to the presence of HAS or pervious clots. ResultsFifty-three patients were included. The dHU was positively correlated with erythrocyte fractions (r = 0.337, p = 0.014), while there was no significant association between aHU and erythrocyte components (r = 0.146, p = 0.296). HAS (+) patients showed a comparable proportion of modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3 (94.6% vs. 87.5%, p = 0.740) and modified Rankin Scale score (mRS) 0–2 (35.1% vs. 56.3%, p = 0.152) compared with those HAS (-). Forty-seven cases were available for the analysis of clot perviousness. Clot perviousness was negatively associated with platelet fractions (r = −0.577, p < 0.001). Patients with pervious clots also showed a comparable proportion of mTICI 2b-3 (86.2% vs. 100%, p = 0.283) and mRS 0–2 (37.9% vs. 50.0%, p = 0.416) compared with impervious clots. ConclusionsThis study suggests that relative thrombus density was positively correlated with erythrocyte fractions, while clot perviousness showed a negative relationship with platelet components. Yet, the presence of HAS or pervious clots did not show significant associations with recanalization and clinical outcomes. The conclusions should be drawn with caution.

Per-pass analysis of recanalization and good neurological outcome in thrombectomy for stroke: Systematic review and meta-analysis.

First pass effect (FPE) is defined as achieving a complete recanalization with a single thrombectomy device pass. Although clinically desired, FPE is reached in less than 30% of thrombectomy procedures. Multiple device passes are often necessary to achieve successful or complete recanalization. We performed a systematic review and meta-analysis to determine the recanalization rate after each pass of mechanical thrombectomy and its association with good neurological outcome. A literature search was performed for studies reporting the number of device passes required for either successful (mTICI 2b or higher) or complete (mTICI 2c or higher) recanalization. Using random-effect meta-analysis, we evaluated the likelihood of recanalization and good neurological outcome (measured with the modified Rankin Score <2 at 90 days) after each device pass. Thirteen studies comprising 4197 patients were included. Among cases with failed first pass, 24% of them achieved final complete recanalization and 45% of them achieved final successful recanalization. Independently to the total number of previously failed attempts, the likelihood of achieving successful recanalization was 30% per pass, and the likelihood to achieve complete recanalization was about 20% per pass. The likelihood of good neurological outcome in patients with final successful recanalization decreased after each device pass: 55% after the first pass, 48% after the second pass, 42% after the third pass, 36% after the fourth pass, and 26% for 5 passes or more. Each pass is associated with a stable likelihood of recanalization but a decreased likelihood of good neurological outcome.

Carotid webs in large vessel occlusion stroke: Clinical, radiological and thrombus histopathological findings

BackgroundCarotid webs are an under-recognized embolic source in patients with cryptogenic stroke. Limited resources currently exist to assist clinicians in stroke prevention for patients with symptomatic carotid webs (SCW). We aimed at analysing the clinical, radiological and procedural features of stroke patients with SCW undergoing endovascular thrombectomy (EVT), and to describe the histopathological composition of their occlusive thrombi. MethodsIn a single-center observational study on consecutive patients with ischemic stroke treated by EVT, carotid web was defined symptomatic when it was ipsilateral to the ischemic lesion in a patient classified with stroke of otherwise undetermined etiology. Clinical, radiological and procedural data of patients with SCW were evaluated. Histopathological examination of the retrieved thrombi was performed. ResultsOut of 1430 patients with large vessel occlusion stroke treated by EVT, 11(0.7%) were found to have a SCW. Patients with SCW had a median age of 47 years old (IQR 38–50), they were prevalently women (55%), mostly of African ethnicity (91%). Each of the 11 patients achieved successful angiographic reperfusion (mTICI 2b-3) after EVT. For secondary prevention, elective endovascular carotid stenting was performed in 5 (55%) patients, while 1 (9%) was treated by surgical endoarterectomy. Histological analysis of the retrieved thrombi performed in 4 patients showed a mixed composition with variable red blood cell content. ConclusionsEVT is feasible in large vessel occlusion stroke related to SCW. Procedures of carotid revascularization appear to be feasible therapeutic options for secondary prevention. The histopathological analysis of cerebral thrombi may provide new insights on stroke pathogenesis in patients with SCW.

Long-term outcomes of thrombectomy for acute ischaemic stroke by occluded artery and stroke aetiology: a PRAGUE-16 substudy.

Thrombectomy is an effective treatment for acute ischaemic stroke (AIS). The aim of this study was to compare clinical outcomes with intracranial artery occlusion site among AIS patients treated in the setting of a cardiology cath lab. This was a single-centre, prospective registry of 214 consecutive patients with AIS enrolled between 2012 and 2018. All thrombectomy procedures were performed in a cardiology cath lab with stent retrievers or aspiration systems. The functional outcome was assessed by the modified Rankin Scale (mRS) after three months. Ninety-three patients (44%) had middle cerebral artery (MCA) occlusion, 28 patients (13%) had proximal internal carotid artery (ICA) occlusion, 27 patients (13%) had tandem (ICA+MCA) occlusion, 39 patients (18%) had terminal ICA (T-type) occlusion, and 26 patients (12%) had vertebrobasilar (VB) stroke. Favourable clinical outcome (mRS ≤2) was reached in 58% of MCA occlusions and in 56% of isolated ICA occlusions, but in only 31% of T-type occlusions and in 27% of VB stroke. Poor clinical outcome in T-type occlusions and VB strokes was influenced by the lower recanalisation success (mTICI 2b-3 flow) rates: 56% (T-type) and 50% (VB) compared to 82% in MCA occlusions, 89% in isolated ICA occlusions and 96% in tandem occlusions. Catheter-based thrombectomy achieved significantly better clinical results in patients with isolated MCA occlusion, isolated ICA occlusions or tight stenosis and tandem occlusions compared to patients with T-type occlusion and posterior strokes. Visual summary. Endovascular intervention of isolated MCA or ICA occlusions provides greatest clinical benefit, while interventions in posterior circulation have lower chance for clinical success.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide...

Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint.

Background and Purpose: End-of-procedure substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) 2b-3], the leading endpoint for thrombectomy studies, has several limitations including a ceiling effect, with recent achieved rates of ~90%. We aimed to identify a more optimal definition of angiographic success along two dimensions: (1) the extent of tissue reperfusion, and (2) the speed of revascularization.Methods: Core-lab adjudicated TICI scores for the first three passes of EmboTrap and the final all-procedures result were analyzed in the ARISE II multicenter study. The clinical impact of extent of reperfusion and speed of reperfusion (first-pass vs. later-pass) were evaluated. Clinical outcomes included 90-day functional independence [modified Rankin Scale (mRS) 0–2], 90-day freedom-from-disability (mRS 0–1), and dramatic early improvement [24-h National Institutes of Health Stroke Scale (NIHSS) improvement ≥ 8 points].Results: Among 161 ARISE II subjects with ICA or MCA M1 occlusions, reperfusion results at procedure end showed substantial reperfusion in 149 (92.5%), excellent reperfusion in 121 (75.2%), and complete reperfusion in 79 (49.1%). Reperfusion rates on first pass were substantial in 81 (50.3%), excellent reperfusion in 62 (38.5%), and complete reperfusion in 44 (27.3%). First-pass excellent reperfusion (first-pass TICI 2c-3) had the greatest nominal predictive value for 90-day mRS 0–2 (sensitivity 58.5%, specificity 68.6%). There was a progressive worsening of outcomes with each additional pass required to achieve TICI 2c-3.Conclusions: First-pass excellent reperfusion (TICI 2c-3), reflecting rapid achievement of extensive reperfusion, is the technical revascularization endpoint that best predicted functional independence in this international multicenter trial and is an attractive candidate for a lead angiographic endpoint for future trials.Clinical Trial Registration: http://www.clinicaltrials.gov, identifier NCT02488915.

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.

SOFIA catheter for direct aspiration of large vessel occlusion stroke: A single-center cohort and meta-analysis.

Direct aspiration (DA) using large-bore distal aspiration catheters is an established strategy for the endovascular thrombectomy (EVT) of large-vessel occlusion stroke (LVOS). However, the performance of individual catheters like SOFIA has yet to be examined. We present a cohort of 144 consecutive patients treated with first-line DA and SOFIA 6 F Plus catheter for LVOS. We also conducted a systematic review of the literature searching multiple databases for reports on thrombectomy with DA and SOFIA catheters and performed a meta-analysis of recanalization, safety, and clinical outcomes. In the study cohort a successful recanalization (mTICI 2b-3) rate of 75.7% was achieved with DA alone, the global rate for functional independence (90-day mRS 0-2) was 40.3%. For the metanalysis we selected nine articles that included a total of 758 patients treated with first-line thrombectomy with the SOFIA catheters. The mTICI 2b-3 rate was 71.6% (95%CI, 66.3-76.5%) while a rescue stent-retriever was used in 24.1% (95%CI, 17.7-31.9%) of cases. The overall mTICI2b-3 rate after DA and rescue therapy was 88.9% (95%CI, 82.6-93.1%). We found a pooled estimate of 45.6% (95%CI, 38.6-52.8%) for functional independence, a mortality within 90 days of 19% (95%CI, 14.1-25.0%) and a rate of 5.8% (95%CI, 4.2-8.0%) of symptomatic intracranial hemorrhage. The DA approach for LVOS with the SOFIA catheters is highly effective with an efficacy and safety profile comparable to those found in contemporary thrombectomy trials and observational studies that use other devices or approaches.