Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

Summary

Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.

Timeline

Start

2010-05

Primary completion

2015-09

Completion

2015-09

Publications

• Background Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
• Background Ernst R, Pancioli A, Tomsick T, Kissela B, Woo D, Kanter D, Jauch E, Carrozzella J, Spilker J, Broderick J. Combined intravenous and intra-arterial recombinant tissue plasminogen activator in acute ischemic stroke. Stroke. 2000 Nov;31(11):2552-7. doi: 10.1161/01.str.31.11.2552.
• Background Wolpert SM, Bruckmann H, Greenlee R, Wechsler L, Pessin MS, del Zoppo GJ. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. The rt-PA Acute Stroke Study Group. AJNR Am J Neuroradiol. 1993 Jan-Feb;14(1):3-13.
• Background Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.
• Background Agarwal P, Kumar S, Hariharan S, Eshkar N, Verro P, Cohen B, Sen S. Hyperdense middle cerebral artery sign: can it be used to select intra-arterial versus intravenous thrombolysis in acute ischemic stroke? Cerebrovasc Dis. 2004;17(2-3):182-90. doi: 10.1159/000075789. Epub 2003 Dec 29.
• Background Noser EA, Shaltoni HM, Hall CE, Alexandrov AV, Garami Z, Cacayorin ED, Song JK, Grotta JC, Campbell MS 3rd. Aggressive mechanical clot disruption: a safe adjunct to thrombolytic therapy in acute stroke? Stroke. 2005 Feb;36(2):292-6. doi: 10.1161/01.STR.0000152331.93770.18. Epub 2004 Dec 29.
• Background Berlis A, Lutsep H, Barnwell S, Norbash A, Wechsler L, Jungreis CA, Woolfenden A, Redekop G, Hartmann M, Schumacher M. Mechanical thrombolysis in acute ischemic stroke with endovascular photoacoustic recanalization. Stroke. 2004 May;35(5):1112-6. doi: 10.1161/01.STR.0000124126.17508.d3. Epub 2004 Mar 11.
• Background Schumacher HC, Meyers PM, Yavagal DR, Harel NY, Elkind MS, Mohr JP, Pile-Spellman J. Endovascular mechanical thrombectomy of an occluded superior division branch of the left MCA for acute cardioembolic stroke. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):305-8. doi: 10.1007/s00270-003-2719-5.
• Background Kulcsar Z, Bonvin C, Pereira VM, Altrichter S, Yilmaz H, Lovblad KO, Sztajzel R, Rufenacht DA. Penumbra system: a novel mechanical thrombectomy device for large-vessel occlusions in acute stroke. AJNR Am J Neuroradiol. 2010 Apr;31(4):628-33. doi: 10.3174/ajnr.A1924. Epub 2009 Dec 17.
• Background Bose A, Henkes H, Alfke K, Reith W, Mayer TE, Berlis A, Branca V, Sit SP; Penumbra Phase 1 Stroke Trial Investigators. The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism. AJNR Am J Neuroradiol. 2008 Aug;29(7):1409-13. doi: 10.3174/ajnr.A1110. Epub 2008 May 22.

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