Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Trial: Protocol for a Randomized, Controlled, Multicenter Study Comparing the Solitaire Revascularization Device with IV tPA with IV tPA Alone in Acute Ischemic Stroke

The Rankin scale has no useful discrimination at all except for No. 6 - dead. Because of this type of crappy research we never get anywhere with stroke solutions.
http://wso.sagepub.com/content/10/3/439.full

1. Jeffrey L. Saver1,*
2. Mayank Goyal2,3
3. Alain Bonafe4
4. Hans-Christoph Diener5
5. Elad I. Levy6
6. Vitor M. Pereira7
7. Gregory W. Albers8
8. Christophe Cognard9
9. David J. Cohen10
10. Werner Hacke11
11. Olav Jansen12
12. Tudor G. Jovin13
13. Heinrich P. Mattle14
14. Raul G. Nogueira15
15. Adnan H. Siddiqui16
16. Dileep R. Yavagal17
17. Thomas G. Devlin18
18. Demetrius K. Lopes19
19. Vivek Reddy13
20. Richard du Mesnil de Rochemont20
21. Reza Jahan21
22. for the SWIFT PRIME Investigators

1. ¹ Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA
2. ² Department of Radiology, University of Calgary, Calgary, AB, Canada
3. ³ Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
4. ⁴ Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier, France
5. ⁵ Department of Neurology, University Hospital of University Duisburg-Essen, Essen, Germany
6. ⁶ Department of Neurosurgery, State University of New York at Buffalo, Buffalo, NY, USA
7. ⁷ Division of Neuroradiology, Toronto Western Hospital, Toronto, ON, Canada
8. ⁸ Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, USA
9. ⁹ Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, Toulouse, France
10. ¹⁰ Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
11. ¹¹ Department of Neurology, University of Heidelberg, Heidelberg, Germany
12. ¹² Department of Radiology and Neuroradiology, Christian-Albrechts-University Kiel, Kiel, Germany
13. ¹³ Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
14. ¹⁴ Department of Neurology, Inselspital, University of Bern, Bern, Switzerland
15. ¹⁵ Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA
16. ¹⁶ Department of Neurosurgery, Toshiba Stroke and Vascular Research Center, University at Buffalo State University of New York at Buffalo, Buffalo, NY, USA
17. ¹⁷ Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine/Jackson Memorial Hospital, Miami, FL, USA
18. ¹⁸ Division of Neurology, Erlanger Hospital at University of Tennessee, Chattanooga, TN, USA
19. ¹⁹ Department of Neurosurgery, Rush University Medical Center, Chicago, IL, USA
20. ²⁰ Institute of Neuroradiology, Klinikum der Goethe-Universität, Frankfurt, Germany
21. ²¹ Division of Interventional Neuroradiology, University of California Los Angeles, Los Angeles, CA, USA

1. ↵* Correspondence: Jeffrey L. Saver, UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095, USA. E-mail: jsaver@ucla.edu

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Abstract

Rationale Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions.

Aim The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke.

Design The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled.

Procedures Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset.

Study Outcomes The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure.

Analysis Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2).

• acute ischemic stroke
• clinical trial
• endovascular
• recanalization
• stent retriever
• thrombolysis

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Introduction

Stroke is the second leading cause of death and a leading cause of disability worldwide (1). Cerebral infarction, due to thrombotic occlusion of a brain artery, is the most common stroke type, accounting for 65–85% of all cases. The only specific therapy of demonstrated benefit for acute ischemic stroke (AIS) is intravenous (IV) fibrinolysis with tissue plasminogen activator (tPA) up to 4·5 hours after onset. However, patients with occlusions of large, proximal, intracranial arteries are often not responsive to IV tPA, as lytic therapy achieves early reperfusion in only 13–50% of patients with occlusions in the carotid terminus and the M1 segment of the middle cerebral artery (MCA) (2⇓⇓–5).

The Solitaire™ Flow Restoration (FR) device is a self-expanding stent retriever that restores blood flow in patients experiencing ischemic stroke because of large intracranial vessel occlusion. In multicenter registries and large clinical series, the Solitaire stent retriever has yielded high rates of reperfusion and favorable clinical outcomes (6⇓–8). In a randomized, head-to-head device trial, compared with first-generation, coil retriever devices, use of the Solitaire™ FR was associated with superior recanalization rates, faster achievement of reperfusion, reduced intracranial haemorrhage complications, and improved final disability outcome (9).

The Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial is being undertaken to establish the safety and efficacy of neurothrombectomy with Solitaire in conjunction with IV tPA vs. IV tPA alone, among AIS patients treatable within six-hours of symptom onset.