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  • 1
    Online Resource
    Online Resource
    Thrombectomy in Patients Ineligible for iv tPA (THRILL)
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 6 ( 2015-08), p. 950-955
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 6 ( 2015-08), p. 950-955
    Abstract: A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy. Aims and/or hypothesis The aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute stroke patients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator up to eight-hours of symptom onset. Design ‘Thrombectomy in patients ineligible for iv tPA’ is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study. Study outcome(s) Primary end-point is the modified Rankin Score shift analysis 90 days (±14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score ≤ 1), good neurological outcomes (modified Rankin Score ≤ 2 or National Institutes of Health Stroke Scale improvement ≥ 10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (±6) h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (±14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety endpoints (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (±6) h, death, or dependency). Discussion Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. ‘Thrombectomy in patients ineligible for iv tPA’ may change clinical practice by providing evidence of an effective and safe treatment for such patients.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12527
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2211666-7
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  • 2
    Online Resource
    Online Resource
    The association of arterial shear and flow-mediated dilation in diabetes
    SAGE Publications ; 2011
    In:  Vascular Medicine Vol. 16, No. 4 ( 2011-08), p. 267-274
    Details
    In: Vascular Medicine, SAGE Publications, Vol. 16, No. 4 ( 2011-08), p. 267-274
    Abstract: While adjusting flow-mediated dilation (FMD), a measure of vascular function, for shear rate may be important when evaluating endothelial-dependent vasodilation, the relationship of FMD with shear rate in study populations with cardiovascular risk factors is unclear. We aimed to investigate the association of four measures of shear rate (peak shear rate (SR peak ) and shear rate area under the curve through 30 seconds (SR AUC 0–30 ), 60 seconds (SR AUC 0–60 ), and time to peak dilation (SR AUC 0–ttp )) with FMD in 50 study subjects with type 2 diabetes and mild hypertension undergoing baseline FMD testing for an exercise intervention trial. Associations among measures of shear rate and FMD were evaluated using Pearson’s correlations and R 2 . The four measures of shear rate were highly correlated within subjects, with Pearson’s correlations ranging from 0.783 ( p 〈 0.001) to 0.972 ( p 〈 0.001). FMD was associated with each measure of shear rate, having a correlation of 0.576 ( p 〈 0.001) with SR AUC 0–30 , 0.529 ( p 〈 0.001) with SR AUC 0–60 , and 0.512 ( p 〈 0.001) with SR peak . Nine of 50 subjects (18%) did not dilate following the shear stimulus. Among the 41 responders, FMD had a correlation of 0.517 ( p 〈 0.001) with SR AUC 0–ttp and similar correlations to those found in the full sample for SR AUC 0–30 , SR AUC 0–60 , and SR peak . In conclusion, shear rate appears to explain up to a third of between-person variability in FMD response and our results support the reporting of shear rate and FMD with and without adjustment for shear rate in similar clinical populations with CVD risk factors.
    Type of Medium: Online Resource
    ISSN: 1358-863X , 1477-0377
    URL: Article
    DOI: 10.1177/1358863X11411361
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
    detail.hit.zdb_id: 2027562-6
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  • 3
    Online Resource
    Online Resource
    A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window
    SAGE Publications ; 2019
    In:  International Journal of Stroke Vol. 14, No. 1 ( 2019-01), p. 87-93
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 14, No. 1 ( 2019-01), p. 87-93
    Abstract: The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well). Design TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3–5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized. Outcomes Primary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4–6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment. Discussion TENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493018798558
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2211666-7
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