Mechanical thrombectomy using the new Tigertriever in acute ischemic stroke patients – A Swiss prospective multicenter study

Gruber, Philipp; Diepers, Michael; Hessling, Alexander von; Weber, W.; Kahles, Timo; Añon, Javier; Berberat, Jatta; Nedeltchev, Krassen; Liebeskind, David S; Remonda, Luca

doi:10.1177/1591019920946499

Cited by 12 publications

(10 citation statements)

References 14 publications

(17 reference statements)

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“…The device has had CE mark, the European Union certification indicating conformity with health, safety, and environmental protection, since 2016 and has shown promising signals of efficacy and safety in preliminary case series reported by European centers. [10][11][12] The TIGER trial (Treatment With Intent to Generate Endovascular Reperfusion) was a single-arm, multicenter, prospective study assessing the efficacy and safety of the Tiger-21 and Tiger-17 retrievers. The study employed an objective performance criterion, noninferiority design, comparing efficacy and safety of the Tigertriever with performance goals derived from adjudicated outcomes in 6 completed prospective trials of 2 FDAapproved predicate stent retrievers, Solitaire (Medtronic) and Trevo (Stryker).…”

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confidence: 99%

New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke

Gupta

Saver

Levy

et al. 2021

Stroke

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Background and Purpose: The Tigertriever is a novel, radially adjustable, fully visible, stentriever that permits the operator to align radial expansion with target vessel diameters. This multicenter trial compared the Tigertriever’s effectiveness and safety compared with established stent retrievers. Methods: Single arm, prospective, multicenter trial comparing the Tigertriever to efficacy and safety performance goals derived from outcomes in six recent pivotal studies evaluating the Solitaire and Trevo stent-retriever devices with a lead-in and a main-study phase. Patients were enrolled if they had acute ischemic stroke with NIHSS≥8 due to large vessel occlusion within 8 hours of onset. The primary efficacy endpoint was successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Tigertriever. The primary safety endpoint was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage (sICH). Secondary efficacy endpoints included 3-month good clinical outcome (modified Rankin Scale 0-2) and first-pass successful reperfusion. Results: Between May 2018 and March 2020, 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled and treated with the Tigertriever. The primary efficacy endpoint was achieved in 84.6% in the main-study phase group compared with the 63.4% performance goal and the 73.4% historical rate (non-inferiority p<0.0001; superiority p<0.01). The first pass successful reperfusion rate was 57.8%. After all interventions, successful reperfusion (mTICI ≥2b) was achieved in 95.7% and excellent reperfusion (mTICI 2c-3) in 71.8%. The primary safety composite endpoint rate of mortality and sICH was 18.1% compared with the 30.4% performance goal and the 20.4% historical rate (non-inferiority p=0.004; superiority p=0.57). Good clinical outcome was achieved in 58% at 90 days. Conclusions: The Tigertriever device was shown to be highly effective and safe compared to Trevo and Solitaire devices to remove thrombus in large vessel occlusive stroke patients eligible for mechanical thrombectomy. Registration: URL: http://www.clinicaltrials.gov; Unique identifier: NCT03474549.

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confidence: 99%

New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke

Gupta

Saver

Levy

et al. 2021

Stroke

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“…Newer devices with smaller diameters and very-low-profile thrombectomy devices are being developed for DMVOs. 14,27 The role of anesthesia in DMVO EVT will need to be studied because general anesthesia may be preferred in DMVO to increase the safety profile of EVT in these distal, smaller, and more fragile vessels. The association of tenecteplase with treatment of DMVO strokes will need to be thoroughly investigated.…”

Section: Discussionmentioning

confidence: 99%

Endovascular Therapy vs Medical Management for Patients With Acute Stroke With Medium Vessel Occlusion in the Anterior Circulation

et al. 2022

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ImportanceRandomized clinical trials have shown the efficacy of endovascular therapy (EVT) for acute large vessel occlusion strokes. The benefit of EVT in acute stroke with distal, medium vessel occlusion (DMVO) remains unclear.ObjectiveTo examine the efficacy and safety outcomes associated with EVT in patients with primary DMVO stroke when compared with a control cohort treated with medical management (MM) alone.Design, Setting, and ParticipantsThis multicenter, retrospective cohort study pooled data from patients who had an acute stroke and a primary anterior circulation emergency DMVO, defined as any segment of the anterior cerebral artery (ACA) or distal middle cerebral artery, between January 1, 2015, and December 31, 2019. Those with a concomitant proximal occlusion were excluded. Outcomes were compared between the 2 treatment groups using propensity score methods. Data analysis was performed from March to June 2021.ExposuresPatients were divided into EVT and MM groups.Main Outcomes and MeasuresMain efficacy outcomes included 3-month functional independence (modified Rankin Scale [mRS] scores, 0-2) and 3-month excellent outcome (mRS scores, 0-1). Safety outcomes included 3-month mortality and symptomatic intracranial hemorrhage.ResultsA total of 286 patients with DMVO were evaluated, including 156 treated with EVT (mean [SD] age, 66.7 [13.7] years; 90 men [57.6%]; median National Institute of Health Stroke Scale [NIHSS] score, 13.5 [IQR, 8.5-18.5]; intravenous tissue plasminogen activator [IV tPA] use, 75 [49.7%]; ACA involvement, 49 [31.4%]) and 130 treated with medical management (mean [SD] age, 69.8 [14.9] years; 62 men [47.7%]; median NIHSS score, 7.0 [IQR, 4.0-14.0], IV tPA use, 58 [44.6%]; ACA involvement, 31 [24.0%]). There was no difference in the unadjusted rate of 3-month functional independence in the EVT vs MM groups (151 [51.7%] vs 124 [50.0%]; P = .78), excellent outcome (151 [38.4%] vs 123 [31.7%]; P = .25), or mortality (139 [18.7%] vs 106 [11.3%]; P = .15). The rate of symptomatic intracranial hemorrhage was similar in the EVT vs MM groups (weighted: 4.0% vs 3.1%; P = .90). In inverse probability of treatment weighting propensity analyses, there was no significant difference between groups for functional independence (adjusted odds ratio [aOR], 1.36; 95% CI, 0.84-2.19; P = .20) or mortality (aOR, 1.24; 95% CI, 0.63-2.43; P = .53), whereas the EVT group had higher odds of an excellent outcome (mRS scores, 0-1) at 3 months (aOR, 1.71; 95% CI, 1.02-2.87; P = .04).Conclusions and RelevanceThe findings of this multicenter cohort study suggest that EVT may be considered for selected patients with ACA or distal middle cerebral artery strokes. Further larger randomized investigation regarding the risk-benefit ratio for DMVO treatment is indicated.

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“…microcatheter. The Tigertriever device is CE approved since 2016 and completed several phase 1 trials (54)(55)(56)(57). The investigators of the multicenter TIGER trial recently published their preliminary result.…”

Section: Third-generation Stent Retrieversmentioning

confidence: 99%

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

et al. 2021

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Endovascular thrombectomy (EVT) has been validated in several randomized controlled trials in recent years for its efficacy in the treatment of acute ischemic strokes (AIS) and is now the standard of care according to international guidelines. However, in about 20% of EVT procedures, recanalization is not achieved, and over 50% of patients who undergo EVT still do not have good functional outcome. In this article, we provide an extensive review of the latest evidence and developments in the field of EVT, with particular focus on the factors that improve patient outcomes. These factors include new and adjunctive techniques such as combination of direct aspiration and stent retriever, intra-arterial urokinase or 2b/3a inhibitors, rescue stenting, as well as novel devices including balloon guide catheters and the newer generations of aspiration catheters and stent retrievers. We also examined the latest notion of using first-pass effect (FPE) as the target to achieve during EVT, which has been associated with an improved functional outcome. While the field of EVT has been rapidly evolving, further research is required in specific AIS patient populations such as those with large ischemic core, late presentation beyond 24 h, posterior circulation strokes, and with distal medium vessel occlusion or tandem lesions to better assess its efficacy and safety.

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Mechanical thrombectomy using the new Tigertriever in acute ischemic stroke patients – A Swiss prospective multicenter study

Cited by 12 publications

References 14 publications

New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke

New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke

Endovascular Therapy vs Medical Management for Patients With Acute Stroke With Medium Vessel Occlusion in the Anterior Circulation

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

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