Clinical trial design for endovascular ischemic stroke intervention

Neurology

Volumn 79, Issue 13 SUPPL. 1, 2012, Pages

  Zaidat, Osama O ^a   Liebeskind, David S ^b   Edgell, Randall C ^e   Amlie Lefond, Catherine M ^a   Kalia, Junaid S ^c   Alexandrov, Andrei V ^d  

^a FROEDTERT MEMORIAL LUTHERAN HOSPITAL   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF ALABAMA HOSPITAL   (United States)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

BAYES THEOREM; BRAIN ISCHEMIA; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; HEALTH CARE COST; HUMAN; INFORMED CONSENT; INTERMETHOD COMPARISON; MEDICAL ETHICS; NEUROIMAGING; NONHUMAN; PATIENT CARE; PATIENT MONITORING; PATIENT SAFETY; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STUDY DESIGN; SYSTEMATIC REVIEW; ARTICLE; BLOOD CLOT LYSIS; COMPARATIVE EFFECTIVENESS; LEARNING; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; PREDICTION; PROBABILITY; RANKIN SCALE; REVASCULARIZATION; SAMPLE SIZE; THROMBECTOMY; THROMBOEMBOLISM;

EID: 84867568003     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e31826992cf     Document Type: Article

References (67)

1. Amberson JB, McMahon BT, Pinner M. A clinical trial of sanocrysin in pulmonary tuberculosis. Am Rev Tuberc 1931;24:401-435.
2. Chimowitz MI, Lynn MJ, Howlett-Smith H, et al.; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med 2005;352:1305-1316.
3. Moskowitz SI, Kelly ME, Obuchowski N, Fiorella D. Impact of WASID and Wingspan on the frequency of intracranial angioplasty and stenting at a high volume tertiary care hospital. J NeuroIntervent Surg 2009;1:165-167.
4. Zaidat OO, Klucznik R, Alexander MJ, et al.; NIH Multicenter Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology 2008;70:1518-1524.
5. Chimowitz MI, Lynn MJ, Derdeyn CP, et al.; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 2011;365:993-1003.
6. Molyneux A, Kerr R, Stratton I, et al.; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet 2002;360:1267-1274.
7. Brinjikji W, Rabinstein AA, Lanzino G, Kallmes DF, Cloft HJ. Effect of age on outcomes of treatment of unruptured cerebral aneurysms: a study of the National Inpatient Sample 2001-2008. Stroke 2011;42:1320-1324.
8. Liebeskind DS, Kidwell CS, Sayre JW, Saver JL. Evidence of publication bias in reporting acute stroke clinical trials. Neurology 2006;67:973-979.
9. Kidwell CS, Liebeskind DS, Starkman S, Saver JL. Trends in acute ischemic stroke trials through the 20th century. Stroke 2001;32:1349-1359.
10. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987-1991.
11. Campbell G. Statistics in the world of medical devices: the contrast with pharmaceuticals. J Biopharm Stat 2008;18:4-19.
12. Furlan A, Higashida R, Wechsler L, et al. Intra-arterial prourokinase for acute ischemic stroke: the PROACT II study: a randomized controlled trial. JAMA 1999;282:2003-2011.
13. Khatri P, Hill MD, Palesch YY, et al. Methodology of the Interventional Management of Stroke III trial. Int J Stroke 2008;3:130-137.
14. Ciccone A, Valvassori L, Gasparotti R, Scomazzoni F, Ballabio E, Sterzi R. Debunking 7 myths that hamper the realization of randomized controlled trials on intra-arterial thrombolysis for acute ischemic stroke. Stroke 2007;38:2191-2195.
15. STAIR-II Participants. Stroke Therapy Academic Industry Roundtable II (STAIR-II): recommendations for clinical trial evaluation of acute stroke therapies. Stroke 2001;32:1598-1606.
16. Fisher M, Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke 2003;34:1539-1546.
17. Fisher M, Albers GW, Donnan GA; Stroke Therapy Academic Industry Roundtable IV. Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry Roundtable. Stroke 2005;36:1808-1813.
18. Fisher M, Hanley DF, Howard G, Jauch EC, Warach S; STAIR Group. Recommendations from the STAIR V meeting on acute stroke trials, technology and outcomes. Stroke 2007;38:245-248.
19. Fisher M, Feuerstein G, Howells DW, et al.; STAIR Group. Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke 2009;40:2244-2250.
20. Saver JL, Albers GW, Dunn B, Johnston KC, Fisher M; STAIR VI Consortium. Stroke Therapy Academic Industry Roundtable (STAIR) recommendations for extended window acute stroke therapy trials. Stroke 2009;40:2594-2600.
21. Philip M, Benatar M, Fisher M, Savitz SI. Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. Stroke 2009;40:577-581.
22. Guiloff RJ, ed. Clinical Trials in Neurology. London: Springer-Verlag; 2001.
23. Tomsick TA, Khatri P, Jovin T, et al.; IMS III Executive Committee. Equipoise among recanalization strategies. Neurology 2010;74:1069-1076.
24. Moskop JC. Informed consent and refusal of treatment: challenges for emergency physicians. Emerg Med Clin North Am 2006;24:605-618.
25. Lemaire F. Emergency research: only possible if consent is waived? Curr Opin Crit Care 2007;13:122-125.
26. US Department of Health and Human Services, Office for Human Research Protections. Informed consent. Available at: http://www.hhs.gov/ohrp/policy/ consent/. Accessed February 2012.
27. Clark W, Gantt H. The Gantt Chart, a Working Tool of Management. New York: Ronald Press; 1922. Available at: www.clinicaldevice.com/. Accessed February 2012.
28. Davey Smith G, Egger M. Meta-analysis: unresolved issues and future developments. BMJ 1998;316:221-225.
29. Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. Washington, DC: National Academies Press; 2009.
30. Federal Coordinating Council for Comparative Effectiveness Research. Comparative effectiveness research funding. Available at: www.hhs.gov/recovery/ programs/cer/. Accessed January 21, 2010.
31. Weaver CS, Leonardi-Bee J, Bath-Hextall FJ, Bath PM. Sample size calculations in acute stroke trials: a systematic review of their reporting, characteristics, and relationship with outcome. Stroke 2004;35:1216-1224.
32. Adams HP. Trials of trials in acute ischemic stroke: the Humana Lecture. Stroke 1993;24:1410-1415.
33. Olivot JM, Albers GW. Diffusion-perfusion MRI for triaging transient ischemic attack and acute cerebrovascular syndromes. Curr Opin Neurol 2011;24:44-49.
34. Khatri P, Abruzzo T, Yeatts SD, et al.; IMS I and II Investigators. Good clinical outcome after ischemic stroke with successful revascularization is time-dependent. Neurology 2009;73:1066-1072.
35. Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE). Available at: http://clinicaltrials.gov/ct2/show/NCT00389467?term= MR+ RESCUE&rank=1. Accessed February 2012.
36. Riedel CH, Zimmermann P, Jensen-Kondering U, Stingele R, Deuschl G, Jansen O. The importance of size: successful recanalization by intravenous thrombolysis in acute anterior stroke depends on thrombus length. Stroke 2011;42:1775-1777.
37. Assess the Penumbra System in the Treatment of Acute Stroke (THERAPY). Available at: http://clinicaltrials.gov/ct2/show/NCT01429350?term= NCT01429350&rank=1. Accessed February 2012.
38. Odgaard-Jensen J, Vist GE, Timmer A, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2011;4:MR000012.
39. SOLITAIRE FR With the Intention For Thrombectomy (SWIFT) Study. Available at: http://clinicaltrials.gov/ct2/show/NCT01054560?term=SWIFT&rank=1. Accessed February 2012.
40. Mancini GB, Schulzer M. Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: applications to highly cited trials in cardiovascular medicine. Circulation 1999;99:377-383.
41. Young GA, Lees RK, Weir CJ, for the Glycine Antagonist in Neuroprotection (GAIN) International Trial Steering Committees and Investigators. Strengthening acute stroke trials through optimal use of disability end points. Stroke 2003;34:2676-2680.
42. Saver JL. Novel end point analytic techniques and interpreting shift across the entire range of outcome scales in acute stroke trials. Stroke 2007;38:3055-3062.
43. Broderick JP, Lu M, Kothari R, et al. Finding the most powerful measures of the effectiveness of tissue plasminogen activator in the NINDS tPA stroke trial. Stroke 2000;31:2335-2341.
44. Lees KR. Neuroprotection is unlikely to be effective in humans using current trial designs: an opposing view. Stroke 2002;33:308-309.
45. Savitz SI, Lew R, Bluhmki E, Hacke W, Fisher M. Shift analysis versus dichotomization of the modified Rankin scale outcome scores in the NINDS and ECASS-II trials. Stroke 2007;38:3205-3212.
46. Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke 2009;40:2761-2768.
47. Smith WS, Sung G, Starkman S, et al. Safety and efficacy of mechanical embolectomy in acute ischemic stroke: results of the MERCI trial. Stroke 2005;36:1432-1438.
48. Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chron Dis 1976;29:175-188.
49. Mandava P, Kent TA. A method to determine stroke trial success using multidimensional pooled control functions. Stroke 2009;40:1803-1810.
50. Donnan GA, Davis SM, Berry DA. Clinical trials: is the Bayesian approach ready for prime time? Yes! Stroke 2005;36:1621-1622.
51. Donnan GA, Davis SM, Ludbrook J. The Bayesian principle: can we adapt? Stroke 2005;36:1623-1624.
52. Howard G, Coffey CS, Cutter GR. Is Bayesian analysis ready for use in phase III randomized clinical trials? Beware the sound of the sirens. Stroke 2005;36:1622-1623.
53. Berry DA. Statistical innovations in cancer research. Cancer Med 2003:465-478.
54. Krams M, Lees KR, Hacke W, Grieve AP, Orgogozo J, Ford GA. Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279, 276 in acute ischemic stroke. Stroke 2003;34:2543-2548.
55. Diamond GA, Kaul S. Prior convictions: Bayesian approaches to the analysis and interpretation of clinical mega trials. J Am Coll Cardiol 2004;43:1929-1939.
56. Berry DA, Müller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. Case Studies Bayesian Stat 2001;99-181.
57. Pena C, Li K, Felten R, Ogden N, Melkerson M. An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke. Stroke 2007;38:1988-1992.
58. Dorman PJ, Counsell C, Sandercock P. Reports of randomized trials in acute stroke, 1955 to 1995: what proportions were commercially sponsored? Stroke 1999;30:1995-1998.
59. Thornton A, Lee P. Publication bias in meta-analysis: its causes and consequences. J Clin Epidemiol 2000;53:207-216.
60. Higashida RT, Furlan AJ, Roberts H, et al.; Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiol; Technology Assessment Committee of the Society of Interventional Radiology. Trial design and reporting standards for intraarterial cerebral thrombolysis for acute ischemic stroke. Stroke 2003;34:e109-e137.
61. Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO). Available at: http://clinicaltrials.gov/ct2/show/ NCT01088672?term=ischemic+stroke&rank=7. Accessed February 2012.
62. Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2). Available at: http://clinicaltrials.gov/ct2/show/NCT01270867. Accessed February 2012.
63. El Khoury R, Fisher M, Savitz SI. Current practice versus willingness to enroll in clinical trials: paradox among vascular neurologists about treatment for acute ischemic stroke. Stroke 2010;41:2038-2043.
64. Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008;359:1317-1329.
65. NINDS t-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke: the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995;333:1581-1587.
66. Shuaib A, Bornstein NM, Diener HC, et al.; SENTIS Trial Investigators. Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of Neuro-Flo in Acute Ischemic Stroke Trial. Stroke 2011;42:1680-1690.
67. Ogawa A, Mori E, Minematsu K, et al.; MELT Japan Study Group. 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.