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

Stroke Clinical Trial

Official title:

Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01133223
• Other study ID #: GPPG 09-587
• Status: Withdrawn
• Phase: Phase 2
• First received: May 26, 2010
• Last updated: September 2, 2015
• Start date: May 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient enrolled in acute ischemic stroke protocol

• Up to 3,5h from symptoms onset

• Clinical findings compatible with middle cerebral artery syndrome

• Angiotomographic evidence of proximal middle cerebral artery occlusion

Exclusion Criteria:

• NIHSS < 10

• Overt contraindication to thrombolysis or angiopgraphy

• Disagreement with informed consent term or refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Penumbra™ System
Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)

Drug:
• Recombinant tissue plasminogen activator
Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. Epub 2003 Dec 29. — View Citation

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. Epub 2004 Mar 11. — View Citation

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. — View Citation

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. — View Citation

Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos 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. — View Citation

Kulcsár Z, Bonvin C, Pereira VM, Altrichter S, Yilmaz H, Lövblad KO, Sztajzel R, Rüfenacht 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. — View Citation

Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Büdingen 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. Epub 2007 Dec 20. — View Citation

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. Epub 2004 Dec 29. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional independence (modified Rankin Scale 0-2)		3 months	No
Secondary	Minimal or no disability (modified Rankin Scale 0-1)		3 months	No
Secondary	Overall mortality		7 days and 3 months	Yes
Secondary	Symptomatic cerebral bleeding rate		48 hours, 7 days and 3 months	Yes