Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial: Methodology

Ask your doctor how long it will take to incorporate results from this into the stroke department. 50 years or never is not an acceptable answer. Neither is, 'What research are you referring to?'
http://wso.sagepub.com/content/10/3/429.full

1. Andrew M. Demchuk1,2,3
2. Mayank Goyal1,2
3. Bijoy K. Menon1,3
4. Muneer Eesa1,2
5. Karla J. Ryckborst1
6. Noreen Kamal1,3
7. Shivanand Patil2
8. Sachin Mishra4
9. Mohammed Almekhlafi1,2,5
10. Privia A. Randhawa1
11. Daniel Roy6
12. Robert Willinsky7
13. Walter Montanera8
14. Frank L. Silver9
15. Ashfaq Shuaib10
16. Jeremy Rempel11
17. Tudor Jovin12
18. Donald Frei13
19. Biggya Sapkota14
20. J. Michael Thornton15
21. Alexandre Poppe6
22. Donatella Tampieri16
23. Cheemun Lum17
24. Alain Weill6
25. Tolulope T. Sajobi1,3,18
26. Michael D. Hill1,2,3,18,19,*
27. for the ESCAPE Trial Investigators†

1. ¹ Departments of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
2. ² Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
3. ³ Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
4. ⁴ Department of Clinical Neurosciences, Medanta – The Medicity, Gurgaon, India
5. ⁵ King Abdulaziz University, Jeddah, Saudi Arabia
6. ⁶ CHUM-Hopital Notre Dame, Université de Montréal, Montréal, QC, Canada
7. ⁷ Department of Medical Imaging (Neuroradiology), University Health Network, Toronto Western Hospital, Toronto, ON, Canada
8. ⁸ Department of Radiology (Neuroradiology), Toronto St. Michael's Hospital, Toronto, ON, Canada
9. ⁹ Department of Medicine (Neurology), University Health Network, Toronto Western Hospital, Toronto, ON, Canada
10. ¹⁰ Department of Medicine (Neurology), University of Alberta, Edmonton, AB, Canada
11. ¹¹ Department of Radiology (Neuroradiology), University of Alberta, Edmonton, AB, Canada
12. ¹² Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
13. ¹³ Colorado Neurological Institute, Denver, CO, USA
14. ¹⁴ Erlanger Hospital, Chattanooga, TN, USA
15. ¹⁵ Beaumont Hospital, Dublin, Ireland
16. ¹⁶ Montreal Neurological Institute, McGill University, Montreal, QC, Canada
17. ¹⁷ Ottawa Hospital, Ottawa, ON, Canada
18. ¹⁸ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
19. ¹⁹ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

1. ↵* Correspondence: Michael D. Hill, Calgary Stroke Program, Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Foothills Hospital, Rm 1242A, 1403 29th Street NW, Calgary, Alberta, Canada T2N 2T9. E-mail: michael.hill@ucalgary.ca www.ucalgary.ca/stroketrials

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Abstract

ESCAPE is a prospective, multicenter, randomized clinical trial that will enroll subjects with the following main inclusion criteria: less than 12 h from symptom onset, age > 18, baseline NIHSS >5, ASPECTS score of >5 and CTA evidence of carotid T/L or M1 segment MCA occlusion, and at least moderate collaterals by CTA. The trial will determine if endovascular treatment will result in higher rates of favorable outcome compared with standard medical therapy alone. Patient populations that are eligible include those receiving IV tPA, tPA ineligible and unwitnessed onset or wake up strokes with 12 h of last seen normal. The primary end-point, based on intention-to-treat criteria is the distribution of modified Rankin Scale scores at 90 days assessed using a proportional odds model. The projected maximum sample size is 500 subjects. Randomization is stratified under a minimization process using age, gender, baseline NIHSS, baseline ASPECTS (8–10 vs. 6–7), IV tPA treatment and occlusion location (ICA vs. MCA) as covariates. The study will have one formal interim analysis after 300 subjects have been accrued. Secondary end-points at 90 days include the following: mRS 0–1; mRS 0–2; Barthel 95–100, EuroQOL and a cognitive battery. Safety outcomes are symptomatic ICH, major bleeding, contrast nephropathy, total radiation dose, malignant MCA infarction, hemicraniectomy and mortality at 90 days.