MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: Study protocol for a randomized controlled trial

Trials

Volumn 15, Issue 1, 2014, Pages

  Fransen, Puck S S ^a   Beumer, Debbie ^a,b   Berkhemer, Olvert A ^a,c   van den Berg, Lucie A ^c   Lingsma, Hester ^a   van der Lugt, Aad ^a   van Zwam, Wim H ^b   van Oostenbrugge, Robert J ^b   Roos, Yvo B W E M ^c   Majoie, Charles B ^c   Dippel, Diederik W J ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

Acute ischemic stroke; Alteplase; Endovascular treatment; Randomized controlled trial; Stent; Thrombectomy; Urokinase

Indexed keywords

ALTEPLASE; UROKINASE;

ARTICLE; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; BRAIN INFARCTION SIZE; BRAIN ISCHEMIA; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; MECHANICAL THROMBECTOMY; MULTICENTER STUDY (TOPIC); NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NETHERLANDS; OUTCOME ASSESSMENT; PATIENT SAFETY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RANKIN SCALE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED STUDY; ENDOVASCULAR SURGERY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; STROKE;

BRAIN ISCHEMIA; CLINICAL PROTOCOLS; ENDOVASCULAR PROCEDURES; HUMANS; SAMPLE SIZE; STROKE;

EID: 84908209744     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-343     Document Type: Article

References (47)

1. Wardlaw JM, Murray V, Berge E, Del ZG, Sandercock P, Lindley RL, Cohen G: Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet 2012, 379:2364-2372.
2. 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, 359:1317-1329.
3. Lees KR, Bluhmki E, Von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W, ECASS, Atlantis NINDS, Group, Epithet rt-PA Study, Allen K, Mau J, Meier D, Del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G: Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet 2010, 375:1695-1703.
4. Beumer DSG, Fonvile S, Van Oostenbrugge RJ, Homburg PJ, Van der Lugt A, Dippel DWJ: Intra-arterial occlusion in acute ischemic stroke: relative frequency in an unselected population. Cerebrovasc Dis 2013, 35(S33):66.
5. Derex L, Nighoghossian N, Hermier M, Adeleine P, Froment JC, Trouillas P: Early detection of cerebral arterial occlusion on magnetic resonance angiography: predictive value of the baseline NIHSS score and impact on neurological outcome. Cerebrovasc Dis 2002, 13:225-229.
6. Heldner MR, Zubler C, Mattle HP, Schroth G, Weck A, Mono ML, Gralla J, Jung S, El-Koussy M, Ludi R, Yan X, Arnold M, Ozdoba C, Mordasini P, Fischer U: National Institutes of Health stroke scale score and vessel occlusion in 2152 patients with acute ischemic stroke. Stroke 2013, 44:1153-1157.
7. Alexandrov AV: Ultrasound enhanced thrombolysis for stroke. Int J Stroke 2006, 1:26-29.
8. Del Zoppo GJ, Higashida RT, Furlan AJ, Pessin MS, Rowley HA, Gent M: PROACT: a phase II randomized trial of recombinant pro-urokinase by direct arterial delivery in acute middle cerebral artery stroke: PROACT Investigators: prolyse in acute cerebral thromboembolism. Stroke 1998, 29:4-11.
9. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F: Intra-arterial prourokinase for acute ischemic stroke: The PROACT II study: a randomized controlled trial: prolyse in acute cerebral thromboembolism. JAMA 1999, 282:2003-2011.
10. Ogawa A, Mori E, Minematsu K, Taki W, Takahashi A, Nemoto S, Miyamoto S, Sasaki M, Inoue T: Randomized trial of intraarterial infusion of urokinase within 6 hours of middle cerebral artery stroke: the middle cerebral artery embolism local fibrinolytic intervention trial (MELT) Japan. Stroke 2007, 38:2633-2639.
11. Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, Von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA: Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med 2013, 368:893-903.
12. Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E, SYNTHESIS Expansion Investigators: Endovascular treatment for acute ischemic stroke. N Engl J Med 2013, 368:904-913.
13. Lewandowski CA, Frankel M, Tomsick TA, Broderick J, Frey J, Clark W, Starkman S, Grotta J, Spilker J, Khoury J, Brott T: Combined intravenous and intra-arterial r-TPA versus intra-arterial therapy of acute ischemic stroke: Emergency Management of Stroke (EMS) bridging trial. Stroke 1999, 30:2598-2605.
14. IMS Study Investigators: Combined intravenous and intra-arterial recanalization for acute ischemic stroke: the interventional management of stroke study. Stroke 2004, 35:904-911.
15. II Trial Ims Investigators: The Interventional Management of Stroke (IMS) II study. Stroke 2007, 38:2127-2135.
16. 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, 31:2552-2557.
17. Wolfe T, Suarez JI, Tarr RW, Welter E, Landis D, Sunshine JL, Zaidat OO: Comparison of combined venous and arterial thrombolysis with primary arterial therapy using recombinant tissue plasminogen activator in acute ischemic stroke. J Stroke Cerebrovasc Dis 2008, 17:121-128.
18. Suarez JI, Zaidat OO, Sunshine JL, Tarr R, Selman WR, Landis DM: Endovascular administration after intravenous infusion of thrombolytic agents for the treatment of patients with acute ischemic strokes. Neurosurgery 2002, 50:251-259.
19. Hill MD, Barber PA, Demchuk AM, Newcommon NJ, Cole-Haskayne A, Ryckborst K, Sopher L, Button A, Hu W, Hudon ME, Morrish W, Frayne R, Sevick RJ, Buchan AM: Acute intravenous-intra-arterial revascularization therapy for severe ischemic stroke. Stroke 2002, 33:279-282.
20. Shaltoni HM, Albright KC, Gonzales NR, Weir RU, Khaja AM, Sugg RM, Campbell MS III, Cacayorin ED, Grotta JC, Noser EA: Is intra-arterial thrombolysis safe after full-dose intravenous recombinant tissue plasminogen activator for acute ischemic stroke? Stroke 2007, 38:80-84.
21. Sohn SI, Cho KH, Chang HW, Park SW: Predictors of hemorrhagic transformation after multimodal intra-arterial reperfusion therapy for acute ischemic stroke. Cerebrovasc Dis 2009, 27:143-143.
22. Kidwell CS, Jahan R, Gornbein J, Alger JR, Nenov V, Ajani Z, Feng L, Meyer BC, Olson S, Schwamm LH, Yoo AJ, Marshall RS, Meyers PM, Yavagal DR, Wintermark M, Guzy J, Starkman S, Saver JL, MR RESCUE Investigators: A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med 2013, 368:914-923.
23. Nogueira RG, Yoo AJ, Buonanno FS, Hirsch JA: Endovascular approaches to acute stroke, part 2: a comprehensive review of studies and trials. AJNR Am J Neuroradiol 2009, 30:859-875.
24. Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Trialists S: Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet 2012, 380:1241-1249.
25. Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS: Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet 2012, 380:1231-1240.
26. Arnold M, Schroth G, Nedeltchev K, Loher T, Remonda L, Stepper F, Sturzenegger M, Mattle HP: Intra-arterial thrombolysis in 100 patients with acute stroke due to middle cerebral artery occlusion. Stroke 2002, 33:1828-1833.
27. Puetz V, Dzialowski I, Hill MD, Subramaniam S, Sylaja PN, Krol A, O'Reilly C, Hudon ME, Hu WY, Coutts SB, Barber PA, Watson T, Roy J, Demchuk AM, Calgary CTA, Study Group: Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke 2008, 3:230-236.
28. Adams HP, Woolson RF, Clarke WR, Davis PH, Bendixen BH, Love BB, Wasek PA, Grimsman KJ: Design of the trial of Org 10172 in acute stroke treatment (TOAST). Control Clin Trials 1997, 18:358-377.
29. EuroQol Group T: EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
30. Mahoney FI, Barthel DW: Functional evaluation: the Barthel Index. Md State Med J 1965, 14:61-65.
31. Saver JL: Novel end point analytic techniques and interpreting shifts across the entire range of outcome scales in acute stroke trials. Stroke 2007, 38:3055-3062.
32. McHugh GS, Butcher I, Steyerberg EW, Marmarou A, Lu J, Lingsma HF, Weir J, Maas AI, Murray GD: A simulation study evaluating approaches to the analysis of ordinal outcome data in randomized controlled trials in traumatic brain injury: results from the IMPACT Project. Clin Trials 2010, 7:44-57.
33. Whitehead J: Sample size calculations for ordered categorical data. Stat Med 1993, 12:2257-2271.
34. Freedman B: Equipoise and the ethics of clinical research. N Engl J Med 1987, 317:141-145.
35. European Carotid Surgery Trialists' Collaborative Group: Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. Lancet 1991, 337:1235-1243.
36. Schulz K, Altman D, Moher D, CONSORT Group: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 11:32.
37. van der Hoeven EJ, Schonewille WJ, Vos JA, Algra A, Audebert HJ, Berge E, Ciccone A, Mazighi M, Michel P, Muir KW, Obach V, Puetz V, Wijman CA, Zini A, Kappelle JL, Basics Study Group: The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial. Trials 2013, 14:200.
38. Bracard S, Ducrocq X, Guillemin F, Hosseini K, THRACE Investigators: THRACE: randomized trial and cost effectiveness evaluation on thrombectomy in acute ischemic stroke. Stroke 2013, 44:AWMP4.
39. PISTE: A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared With Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke Due to an Occluded Major Intracranial Vessel. http://clinicaltrials.gov/ct2/show/NCT01745692.
40. Solitaire™ FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME). http://www.clinicaltrials.gov/show/NCT01657461.
41. Campbell BC, Mitchell PJ, Yan B, Parsons MW, Christensen S, Churilov L, Dowling RJ, Dewey H, Brooks M, MiteffF, Levi C, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Kleinig T, Scroop R, Chryssidis S, Barber A, Hope A, Moriarty M, McGuinness B, Wong AA, Coulthard A, Wijeratne T, Lee A, Jannes J, Leyden J, Phan TG, Chong W, et al: A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA). Int J Stroke 2014, 9:126-132.
42. The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke. http://clinicaltrials.gov/show/NCT01429350.
43. POSITIVE: PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy. http://clinicaltrials.gov/show/NCT01852201.
44. Hill MD: Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE). http://clinicaltrials.gov/show/NCT01778335.
45. Molina CA, Chamorro A, Rovira A, De Miquel A, Serena J, Roman LS, Jovin TG, Davalos A, Cobo E: REVASCAT: a randomized trial of revascularization with SOLITAIRE FR(R) device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset. Int J Stroke 2013, Epub Nov 10.
46. Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial. http://clinicaltrials.gov/show/NCT01657461.
47. Truelsen T, Piechowski-Jozwiak B, Bonita R, Mathers C, Bogousslavsky J, Boysen G: Stroke incidence and prevalence in Europe: a review of available data. Eur J Neurol 2006, 13:581-598.