Skip to main content

Advertisement

SpringerLink
Log in

Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - A position paper endorsed by ESMINT and ESNR

Part II: methodology of future trials

  • Invited Review
  • Published:
Neuroradiology Aims and scope Submit manuscript

Abstract

Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Abbreviations

ASPECTS:

Alberta Stroke Program Early CT

BCO:

Balloon guiding catheter occlusion

BMT:

Best medical therapy

CAS:

Carotid stenting

CBF:

Cerebral blood flow

CBV:

Cerebral blood volume

CCA:

Common carotid artery

CEA:

Carotid endarterectomy

CS:

Conscious sedation

CTA:

CT-angiography

CTP:

CT-perfusion

DSA:

Digital subtraction angiography

DWI:

Diffusion weighted imaging

EIC:

Early ischemic signs

ESMINT:

European Society of Minimally Invasive Neurological Therapy

ESNR:

European Society of Neuroradiology

ESO:

European Stroke Organisation

FU:

Follow up

GA:

General anaesthesia

ICA:

Internal carotid artery

IMS III:

Interventional Management of Stroke III Trial

IVT:

Intravenous thrombolytical therapy

MCA:

Middle cerebral artery

mRS:

Modified rankin scale

MT:

Mechanical thrombectomy

NE-CT:

Non-enhanced CT

NIH-SS:

National Institute of Health Stroke Scale

PI:

Perfusion MRI

RCT:

Randomised control trial

sICH:

Symptomatic intracranial haemorrhage

stent-triever:

Self-expanding stents

References

  1. Saver JL (2011) Optimal end points for acute stroke therapy trials: best ways to measure treatment effects of drugs and devices. Stroke 42:2356–2362

    Article  PubMed  Google Scholar 

  2. Barclay-Goddard R, Epstein JD, Mayo NE (2009) Response shift: a brief overview and proposed research priorities. Qual Life Res 18:335–346

    Article  PubMed  Google Scholar 

  3. Eckert B, Kusel T, Leppien A, Michels P, Muller-Jensen A, Fiehler J (2011) Clinical outcome and imaging follow-up in acute stroke patients with normal perfusion CT and normal CT angiography. Neuroradiology 53:79–88

    Article  PubMed  Google Scholar 

  4. Mlynash M, Lansberg MG, De Silva DA et al (2011) Refining the definition of the malignant profile: insights from the DEFUSE-EPITHET pooled data set. Stroke 42:1270–1275

    Article  PubMed  Google Scholar 

  5. Thomalla G, Hartmann F, Juettler E et al (2010) Prediction of malignant middle cerebral artery infarction by magnetic resonance imaging within 6 hours of symptom onset: a prospective multicenter observational study. Ann Neurol 68:435–445

    Article  PubMed  Google Scholar 

  6. Minnerup J, Wersching H, Ringelstein EB et al (2011) Prediction of malignant middle cerebral artery infarction using computed tomography-based intracranial volume reserve measurements. Stroke 42:3403–3409

    Article  PubMed  Google Scholar 

  7. Coutts SB, Modi J, Patel SK, Demchuk AM, Goyal M, Hill MD (2012) CT/CT angiography and MRI findings predict recurrent stroke after transient ischemic attack and minor stroke: results of the prospective CATCH study. Stroke 43:1013–1017

    Article  PubMed  Google Scholar 

  8. von Kummer R, Allen KL, Holle R et al (1997) Acute stroke: usefulness of early CT findings before thrombolytic therapy. Radiology 205:327–333

    Google Scholar 

  9. Barber PA, Demchuk AM, Zhang J, Buchan AM (2000) Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet 355:1670–1674

    Article  PubMed  CAS  Google Scholar 

  10. Menon BK, Puetz V, Kochar P, Demchuk AM (2011) ASPECTS and other neuroimaging scores in the triage and prediction of outcome in acute stroke patients. Neuroimaging Clin N Am 21:407–423, xii

    Article  PubMed  Google Scholar 

  11. Sillanpaa N, Saarinen JT, Rusanen H et al (2011) The clot burden score, the Boston Acute Stroke Imaging Scale, the cerebral blood volume ASPECTS, and two novel imaging parameters in the prediction of clinical outcome of ischemic stroke patients receiving intravenous thrombolytic therapy. Neuroradiology

  12. Goyal M, Menon BK, Coutts SB, Hill MD, Demchuk AM (2011) Effect of baseline CT scan appearance and time to recanalization on clinical outcomes in endovascular thrombectomy of acute ischemic strokes. Stroke 42:93–97

    Article  PubMed  Google Scholar 

  13. Riedel CH, Jensen U, Rohr A et al (2010) Assessment of thrombus in acute middle cerebral artery occlusion using thin-slice nonenhanced Computed Tomography reconstructions. Stroke 41:1659–1664

    Article  PubMed  Google Scholar 

  14. Riedel CH, Zimmermann P, Jensen-Kondering U, Stingele R, Deuschl G, Jansen O (2011) The importance of size: successful recanalization by intravenous thrombolysis in acute anterior stroke depends on thrombus length. Stroke 42:1775–1777

    Article  PubMed  Google Scholar 

  15. Lev MH (2012) Acute stroke imaging: what is sufficient for triage to endovascular therapies? Ajnr Am J Neuroradiol 33:790–792

    Article  PubMed  CAS  Google Scholar 

  16. Fiehler J, Foth M, Kucinski T et al (2002) Severe ADC decreases do not predict irreversible tissue damage in humans. Stroke 33:79–86

    Article  PubMed  Google Scholar 

  17. Fiehler J, Knudsen K, Kucinski T et al (2004) Predictors of apparent diffusion coefficient normalization in stroke patients. Stroke 35:514–519

    Article  PubMed  Google Scholar 

  18. Yoo AJ, Chaudhry ZA, Nogueira RG et al (2012) Infarct volume is a pivotal biomarker after intra-arterial stroke therapy. Stroke 43:1323–1330

    Article  PubMed  CAS  Google Scholar 

  19. Puetz V, Dzialowski I, Hill MD et al (2008) Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke 3:230–236

    Article  PubMed  Google Scholar 

  20. Alfke K, Jensen U, Pool C et al (2011) Contrast-enhanced magnetic resonance angiography in stroke diagnostics: additional information compared with time-of-flight magnetic resonance angiography? Clin Neuroradiol 21:5–10

    Article  PubMed  CAS  Google Scholar 

  21. Wintermark M, Sincic R, Sridhar D, Chien JD (2008) Cerebral perfusion CT: technique and clinical applications. J Neuroradiol 35:253–260

    Article  PubMed  CAS  Google Scholar 

  22. Dani KA, Thomas RG, Chappell FM et al (2011) Computed tomography and magnetic resonance perfusion imaging in ischemic stroke: definitions and thresholds. Ann Neurol 70:384–401

    Article  PubMed  Google Scholar 

  23. Pulli B, Schaefer PW, Hakimelahi R et al (2012) Acute ischemic stroke: infarct core estimation on CT angiography source images depends on CT angiography protocol. Radiology 262:593–604

    Article  PubMed  Google Scholar 

  24. Rosso C, Colliot O, Valabregue R et al (2011) Tissue at risk in the deep middle cerebral artery territory is critical to stroke outcome. Neuroradiology 53:763–771

    Article  PubMed  Google Scholar 

  25. Wu O, Christensen S, Hjort N et al (2006) Characterizing physiological heterogeneity of infarction risk in acute human ischaemic stroke using MRI. Brain 129:2384–2393

    Article  PubMed  Google Scholar 

  26. Willats L, Connelly A, Christensen S, Donnan GA, Davis SM, Calamante F (2012) The role of bolus delay and dispersion in predictor models for stroke. Stroke

  27. Solomon MJ, McLeod RS (1995) Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 118:459–467

    Article  PubMed  CAS  Google Scholar 

  28. Fiehler J, Bakke SJ, Clifton A et al (2010) Plea of the defence-critical comments on the interpretation of EVA3S, SPACE and ICSS. Neuroradiology 52:601–610

    Article  PubMed  Google Scholar 

  29. Halm EA, Lee C, Chassin MR (2002) Is volume related to outcome in health care? A systematic review and methodologic critique of the literature. Ann Intern Med 137:511–520

    PubMed  Google Scholar 

  30. van der Linden W (1980) Pitfalls in randomized surgical trials. Surgery 87:258–262

    PubMed  Google Scholar 

  31. Verzini F, De Rango P, Parlani G, Panuccio G, Cao P (2008) Carotid artery stenting: technical issues and role of operators' experience. Perspect Vasc Surg Endovasc Ther 20:247–257

    Article  PubMed  Google Scholar 

  32. Brinjikji W, Cloft HJ, Fiorella D, Lanzino G, Kallmes DF (2011) Estimating the proportion of intracranial aneurysms likely to be amenable to treatment with the pipeline embolization device. J Neurointerv Surg

  33. Verzini F, Cao P, De Rango P et al (2006) Appropriateness of learning curve for carotid artery stenting: an analysis of periprocedural complications. J Vasc Surg 44:1205–1211, discussion 1211-1202

    Article  PubMed  Google Scholar 

  34. Mas JL, Chatellier G (2008) Carotid angioplasty and stenting. Stroke 39:e19–e20

    Article  PubMed  Google Scholar 

  35. Ederle J, Dobson J, Featherstone RL et al (2010) Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 375:985–997

    Article  PubMed  Google Scholar 

  36. Kadkhodayan Y, Cross DT 3rd, Derdeyn CP, Moran CJ (2007) Carotid angioplasty and stenting in the elderly. Neuroradiology 49:933–938

    Article  PubMed  Google Scholar 

  37. Rothwell PM, Warlow CP (1999) Interpretation of operative risks of individual surgeons. European Carotid Surgery Trialists' Collaborative Group. Lancet 353:1325

    Article  PubMed  CAS  Google Scholar 

  38. Menon BK, Goyal M (2011) A systems approach towards intra-arterial management of acute ischemic stroke: need for novel outcome measures and a focus on sequence rather than steps. Interv Neuroradiol 17:296–298

    PubMed  CAS  Google Scholar 

  39. Fiehler J, Jansen O, Berger J, Eckstein HH, Ringleb PA, Stingele R (2008) Differences in complication rates among the centres in the SPACE study. Neuroradiology 50:1049–1053

    Article  PubMed  Google Scholar 

  40. Brinjikji W, Rabinstein AA, Lanzino G, Kallmes DF, Cloft HJ (2011) Patient outcomes are better for unruptured cerebral aneurysms treated at centers that preferentially treat with endovascular coiling: a study of the national inpatient sample 2001-2007. Ajnr Am J Neuroradiol 32:1065–1070

    Article  PubMed  CAS  Google Scholar 

  41. Heck DV (2012) Do no harm: the rush to abbreviated training of stroke interventionalists is premature and ill advised. J Neurointerv Surg 4:3–6

    Article  PubMed  Google Scholar 

  42. Hopkins LN, Roubin GS, Chakhtoura EY et al (2010) The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis 19:153–162

    Article  PubMed  Google Scholar 

  43. Chimowitz MI, Lynn MJ, Derdeyn CP et al (2011) Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 365:993–1003

    Article  PubMed  CAS  Google Scholar 

  44. Abou-Chebl A, Lin R, Hussain MS et al (2010) Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke 41:1175–1179

    Article  PubMed  CAS  Google Scholar 

  45. McDonagh DL, Olson DM, Kalia JS, Gupta R, Abou-Chebl A, Zaidat OO (2010) Anesthesia and sedation practices among neurointerventionalists during acute ischemic stroke endovascular therapy. Front Neurol 1:118

    PubMed  Google Scholar 

  46. Davis MJ, Menon BK, Baghirzada LB et al (2012) Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology 116:396–405

    Article  PubMed  CAS  Google Scholar 

  47. Jumaa MA, Zhang F, Ruiz-Ares G et al (2010) Comparison of safety and clinical and radiographic outcomes in endovascular acute stroke therapy for proximal middle cerebral artery occlusion with intubation and general anesthesia versus the nonintubated state. Stroke 41:1180–1184

    Article  PubMed  Google Scholar 

  48. Nichols C, Carrozzella J, Yeatts S, Tomsick T, Broderick J, Khatri P (2010) Is periprocedural sedation during acute stroke therapy associated with poorer functional outcomes? J Neurointerv Surg 2:67–70

    Article  PubMed  CAS  Google Scholar 

  49. Eesa M, Almekhlafi MA, Mitha AP, Wong JH, Goyal M (2012) Manual aspiration thrombectomy through balloon-tipped guide catheter for rapid clot burden reduction in endovascular therapy for ICA L/T occlusion. Neuroradiology

  50. (2009) 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 40:2761-2768

  51. Costalat V, Machi P, Lobotesis K et al (2011) Rescue, combined, and stand-alone thrombectomy in the management of large vessel occlusion stroke using the solitaire device: a prospective 50-patient single-center study: timing, safety, and efficacy. Stroke 42:1929–1935

    Article  PubMed  Google Scholar 

  52. Gralla J, Schroth G, Remonda L, Nedeltchev K, Slotboom J, Brekenfeld C (2006) Mechanical thrombectomy for acute ischemic stroke: thrombus-device interaction, efficiency, and complications in vivo. Stroke 37:3019–3024

    Article  PubMed  Google Scholar 

  53. Davalos Aea (2012) Stroke in press

  54. Lazzaro MA, Zaidat OO (2012) Multimodal endovascular reperfusion therapies: adjunctive antithrombotic agents in acute stroke. Neurology 78:501–506

    Article  PubMed  CAS  Google Scholar 

  55. Smith WS, Sung G, Saver J et al (2008) Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke 39:1205–1212

    Article  PubMed  Google Scholar 

  56. (2007) The Interventional Management of Stroke (IMS) II Study. Stroke 38:2127-2135

  57. del Zoppo GJ, Higashida RT, Furlan AJ, Pessin MS, Rowley HA, Gent M (1998) 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 29:4–11

    Article  PubMed  Google Scholar 

  58. Nahab F, Walker GA, Dion JE, Smith WS (2011) Safety of Periprocedural Heparin in Acute Ischemic Stroke Endovascular Therapy: The Multi MERCI Trial. J Stroke Cerebrovasc Dis

  59. (2000) Abciximab in acute ischemic stroke: a randomized, double-blind, placebo-controlled, dose-escalation study. The Abciximab in Ischemic Stroke Investigators. Stroke 31:601-609

  60. (2005) Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial. Stroke 36:880-890

  61. Adams HP Jr, Effron MB, Torner J et al (2008) Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of an international phase III trial: Abciximab in Emergency Treatment of Stroke Trial (AbESTT-II). Stroke 39:87–99

    Article  PubMed  CAS  Google Scholar 

  62. Lee DH, Jo KD, Kim HG et al (2002) Local intraarterial urokinase thrombolysis of acute ischemic stroke with or without intravenous abciximab: a pilot study. J Vasc Interv Radiol 13:769–774

    Article  PubMed  Google Scholar 

  63. Eckert B, Koch C, Thomalla G et al (2005) Aggressive therapy with intravenous abciximab and intra-arterial rtPA and additional PTA/stenting improves clinical outcome in acute vertebrobasilar occlusion: combined local fibrinolysis and intravenous abciximab in acute vertebrobasilar stroke treatment (FAST): results of a multicenter study. Stroke 36:1160–1165

    Article  PubMed  CAS  Google Scholar 

  64. Qureshi AI, Suri MF, Ali Z et al (2005) Intraarterial reteplase and intravenous abciximab for treatment of acute ischemic stroke. A preliminary feasibility and safety study in a non-human primate model. Neuroradiology 47:845–854

    Article  PubMed  Google Scholar 

  65. Mangiafico S, Cellerini M, Nencini P, Gensini G, Inzitari D (2005) Intravenous glycoprotein IIb/IIIa inhibitor (tirofiban) followed by intra-arterial urokinase and mechanical thrombolysis in stroke. Ajnr Am J Neuroradiol 26:2595–2601

    PubMed  Google Scholar 

  66. Kwon JH, Shin SH, Weon YC, Hwang JC, Baik SK (2011) Intra-arterial adjuvant tirofiban after unsuccessful intra-arterial thrombolysis of acute ischemic stroke: preliminary experience in 16 patients. Neuroradiology 53:779–785

    Article  PubMed  Google Scholar 

  67. Gupta R, Vora NA, Horowitz MB et al (2006) Multimodal reperfusion therapy for acute ischemic stroke: factors predicting vessel recanalization. Stroke 37:986–990

    Article  PubMed  Google Scholar 

  68. Shi ZS, Loh Y, Walker G, Duckwiler GR (2010) Endovascular thrombectomy for acute ischemic stroke in failed intravenous tissue plasminogen activator versus non-intravenous tissue plasminogen activator patients: revascularization and outcomes stratified by the site of arterial occlusions. Stroke 41:1185–1192

    Article  PubMed  Google Scholar 

  69. Castano C, Dorado L, Guerrero C et al (2010) Mechanical thrombectomy with the Solitaire AB device in large artery occlusions of the anterior circulation: a pilot study. Stroke 41:1836–1840

    Article  PubMed  Google Scholar 

  70. Machi P, Costalat V, Lobotesis K et al (2012) Solitaire FR thrombectomy system: immediate results in 56 consecutive acute ischemic stroke patients. J Neurointerv Surg 4:62–66

    Article  PubMed  Google Scholar 

  71. Loh Y, Kim D, Shi ZS et al (2010) Higher rates of mortality but not morbidity follow intracranial mechanical thrombectomy in the elderly. AJNR Am J Neuroradiol 31:1181–1185

    Article  PubMed  Google Scholar 

  72. Yin NS, Benavides S, Starkman S et al (2010) Autopsy findings after intracranial thrombectomy for acute ischemic stroke: a clinicopathologic study of 5 patients. Stroke 41:938–947

    Article  PubMed  Google Scholar 

  73. Jansen O (2011) Neurovascular centers–a need for a change. Clin Neuroradiol 21:51

    Article  PubMed  Google Scholar 

  74. Fiehler J, Stapf C (2008) ARUBA–beating natural history in unruptured brain AVMs by intervention. Neuroradiology 50:465–467

    Article  PubMed  Google Scholar 

Download references

Conflict of interest

JF consults for Stryker and Codman, and gives presentations to Covidien, Boehringer Ingelheim, Philips and Siemens MS has a Consultant agreement with Mindframe (now owned by Covidien) and is PI for the Rapid Medical study. FT consults for Stryker and Codman, is on the Codman Board, and has a proctoring agreement and holds workshops for Covidien. RVK receives personal compensation for serving on the Advisory Board of Lundbeck AC, serves as Co-Chair on the Steering Committee of the DIAS-3 and -4 trials, serves on the image adjudication committee for these trials and consults for Synarc; he is Section Editor, Interventional Neuroradiology, of the journal Neuroradiology. MM is a consultant for Synthes, AB Medica/Italy, gives presentations for Johnson & Johnson and has research support from ActiveO. CC consults for Covidien, Stryker, Codman and Microvention. JG is PI of the STAR Study (Covidien).

Author information

Authors and Affiliations

  1. Department of Neuroradiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

    Jens Fiehler

  2. Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden

    Michael Söderman

  3. Department of Neuroradiology, Hôpital neurologique, Centre de Neurosciences Cognitives, Lyon, France

    Francis Turjman

  4. Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh, Edinburgh, UK

    Philip M. White

  5. Department of Neuroradiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway

    Søren Jacob Bakke

  6. Interventional Neuroradiology Unit, University Hospital Careggi, Florence, Italy

    Salvatore Mangiafico

  7. Department of Neuroradiology, University of Dresden, Dresden, Germany

    Rüdiger von Kummer

  8. Department of Neuroradiology, University of Naples, Naples, Italy

    Mario Muto

  9. Service de Neuroradiologie, Hôpital Purpan, Toulouse, France

    Christophe Cognard

  10. Department of Neuroradiology, Inselspital Bern, Bern, Switzerland

    Jan Gralla

Authors
  1. Jens Fiehler
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michael Söderman
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Francis Turjman
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Philip M. White
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Søren Jacob Bakke
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Salvatore Mangiafico
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Rüdiger von Kummer
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Mario Muto
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Christophe Cognard
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jan Gralla
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jens Fiehler.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Fiehler, J., Söderman, M., Turjman, F. et al. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - A position paper endorsed by ESMINT and ESNR. Neuroradiology 54, 1303–1312 (2012). https://doi.org/10.1007/s00234-012-1076-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00234-012-1076-y

Keywords

Search

Navigation