NCT01778335

Brief Summary

The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes. All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed). During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries. Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

January 25, 2013

Last Update Submit

March 20, 2015

Conditions

Ischemic Stroke

Keywords

recanalizationendovascularthrombectomy

Outcome Measures

Primary Outcomes (1)

  • Shift in the mRS score, defined by a proportional odds model.

    90 days

Secondary Outcomes (8)

  • The proportion of patients who achieve a NIHSS score 0-2

    90 days

  • The proportion of patients who achieve a mRS 0-2

    90 days

  • The proportion of patients who achieve a Barthel Index > 90

    90 days

  • EQ5D

    90 days

  • Cognitive outcome - Trailmaking A, B

    90 days

  • +3 more secondary outcomes

Other Outcomes (4)

  • The proportion of patients who suffer a Safety Outcome

    0-90 days

  • Economic (cost-effectiveness) analysis

    90 days

  • Evaluation of waiver/deferral of consent process

    90 days

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Control arm subjects will receive best medical care.

Endovascular thrombectomy/thrombolysis

EXPERIMENTAL

Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Procedure: Endovascular thrombectomy/thrombolysis

Interventions

Endovascular thrombectomy/thrombolysisPROCEDURE

Endovascular mechanical thrombectomy or thrombolysis

Also known as: Endovascular mechanical thrombectomy
Endovascular thrombectomy/thrombolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke
  • Age 18 or greater
  • Onset (last-seen-well) time to randomization time \< 12 hours.
  • Disabling stroke defined as a baseline NIHSS \> 5 at the time of randomization.
  • Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index \> 90. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
  • B. Imaging (Homogeneous target population)
  • Confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs). Anterior temporal artery is not considered an M2.
  • Non-contrast CT and CTA for trial eligibility performed or repeated at ESCAPE stroke center with endovascular suite on-site.
  • Endovascular treatment intended to be initiated (groin puncture) within 60 minutes of baseline non-contrast CT with target baseline non-contrast CT to first recanalization of 90 minutes.
  • Signed informed consent or appropriate signed deferral of consent where approved.

You may not qualify if:

  • Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion.
  • Other confirmation of a moderate to large core defined one of three ways:
  • On a single phase, multiphase or dynamic CTA: no or minimal collaterals in a region greater than 50% of the MCA territory when compared to pial filling on the contralateral side (multiphase/dynamic CTA preferred) OR
  • On CT perfusion (\>8 cm coverage): a low CBV and very low CBF ASPECTS \<6 AND in the symptomatic MCA territory OR
  • On CT perfusion(\<8 cm coverage): a region of low CBV and very low CBF \>1/3 of the CTP imaged symptomatic MCA territory.
  • Groin puncture is not possible within 60 minutes of the first slice of non-contrast CT acquisition (please note that if CTP is performed it should be done after CTA).
  • No femoral pulses or very difficult endovascular access that will result in a non-contrast CT-to-recanalization time that is longer than 90 minutes, or will result in an inability to deliver endovascular therapy.
  • Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
  • Severe contrast allergy or absolute contraindication to iodinated contrast.
  • Suspected intracranial dissection as a cause of stroke.
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  • Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (15)

  • Rajashekar D, Wilms M, MacDonald ME, Schimert S, Hill MD, Demchuk A, Goyal M, Dukelow SP, Forkert ND. Lesion-symptom mapping with NIHSS sub-scores in ischemic stroke patients. Stroke Vasc Neurol. 2022 Apr;7(2):124-131. doi: 10.1136/svn-2021-001091. Epub 2021 Nov 25.

    PMID: 34824139DERIVED

  • Sevick LK, Demchuk AM, Shuaib A, Smith EE, Rempel JL, Butcher K, Menon BK, Jeerakathil T, Kamal N, Thornton J, Williams D, Poppe AY, Roy D, Goyal M, Hill MD, Clement F; ESCAPE Trialists. A Prospective Economic Evaluation of Rapid Endovascular Therapy for Acute Ischemic Stroke. Can J Neurol Sci. 2021 Nov;48(6):791-798. doi: 10.1017/cjn.2021.4. Epub 2021 Jan 12.

    PMID: 33431075DERIVED

  • Ospel JM, Singh N, Almekhlafi MA, Menon BK, Butt A, Poppe AY, Jadhav A, Silver FL, Shah R, Dowlatshahi D, O'Hare AM, Demchuk AM, Goyal M, Hill MD. Early Recanalization With Alteplase in Stroke Because of Large Vessel Occlusion in the ESCAPE Trial. Stroke. 2021 Jan;52(1):304-307. doi: 10.1161/STROKEAHA.120.031591. Epub 2020 Nov 20.

    PMID: 33213288DERIVED

  • Ganesh A, Menon BK, Assis ZA, Demchuk AM, Al-Ajlan FS, Al-Mekhlafi MA, Rempel JL, Shuaib A, Baxter BW, Devlin T, Thornton J, Williams D, Poppe AY, Roy D, Krings T, Casaubon LK, Kashani N, Hill MD, Goyal M. Discrepancy between post-treatment infarct volume and 90-day outcome in the ESCAPE randomized controlled trial. Int J Stroke. 2021 Jul;16(5):593-601. doi: 10.1177/1747493020929943. Epub 2020 Jun 9.

    PMID: 32515694DERIVED

  • Kaneko N, Komuro Y, Yokota H, Tateshima S. Stent retrievers with segmented design improve the efficacy of thrombectomy in tortuous vessels. J Neurointerv Surg. 2019 Feb;11(2):119-122. doi: 10.1136/neurintsurg-2018-014061. Epub 2018 Jul 24.

    PMID: 30045949DERIVED

  • Brigdan M, Hill MD, Jagdev A, Kamal N. Novel Interactive Data Visualization: Exploration of the ESCAPE Trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times) Data. Stroke. 2018 Jan;49(1):193-196. doi: 10.1161/STROKEAHA.117.018814. Epub 2017 Dec 4.

    PMID: 29203689DERIVED

  • Evans JW, Graham BR, Pordeli P, Al-Ajlan FS, Willinsky R, Montanera WJ, Rempel JL, Shuaib A, Brennan P, Williams D, Roy D, Poppe AY, Jovin TG, Devlin T, Baxter BW, Krings T, Silver FL, Frei DF, Fanale C, Tampieri D, Teitelbaum J, Iancu D, Shankar J, Barber PA, Demchuk AM, Goyal M, Hill MD, Menon BK; ESCAPE Trial Investigators. Time for a Time Window Extension: Insights from Late Presenters in the ESCAPE Trial. AJNR Am J Neuroradiol. 2018 Jan;39(1):102-106. doi: 10.3174/ajnr.A5462. Epub 2017 Nov 30.

    PMID: 29191873DERIVED

  • Sajobi TT, Singh G, Lowerison MW, Engbers J, Menon BK, Demchuk AM, Goyal M, Hill MD. Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial. Trials. 2017 Nov 2;18(1):516. doi: 10.1186/s13063-017-2264-1.

    PMID: 29096678DERIVED

  • Assis Z, Menon BK, Goyal M, Demchuk AM, Shankar J, Rempel JL, Roy D, Poppe AY, Yang V, Lum C, Dowlatshahi D, Thornton J, Choe H, Burns PA, Frei DF, Baxter BW, Hill MD; ESCAPE Trialists. Acute ischemic stroke with tandem lesions: technical endovascular management and clinical outcomes from the ESCAPE trial. J Neurointerv Surg. 2018 May;10(5):429-433. doi: 10.1136/neurintsurg-2017-013316. Epub 2017 Oct 11.

    PMID: 29021311DERIVED

  • Sajobi TT, Menon BK, Wang M, Lawal O, Shuaib A, Williams D, Poppe AY, Jovin TG, Casaubon LK, Devlin T, Dowlatshahi D, Fanale C, Lowerison MW, Demchuk AM, Goyal M, Hill MD; ESCAPE Trial Investigators. Early Trajectory of Stroke Severity Predicts Long-Term Functional Outcomes in Ischemic Stroke Subjects: Results From the ESCAPE Trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times). Stroke. 2017 Jan;48(1):105-110. doi: 10.1161/STROKEAHA.116.014456. Epub 2016 Dec 6.

    PMID: 27924049DERIVED

  • Ganesh A, Al-Ajlan FS, Sabiq F, Assis Z, Rempel JL, Butcher K, Thornton J, Kelly P, Roy D, Poppe AY, Jovin TG, Devlin T, Baxter BW, Krings T, Casaubon LK, Frei DF, Choe H, Tampieri D, Teitelbaum J, Lum C, Mandzia J, Phillips SJ, Bang OY, Almekhlafi MA, Coutts SB, Barber PA, Sajobi T, Demchuk AM, Eesa M, Hill MD, Goyal M, Menon BK; ESCAPE Trial Investigators. Infarct in a New Territory After Treatment Administration in the ESCAPE Randomized Controlled Trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times). Stroke. 2016 Dec;47(12):2993-2998. doi: 10.1161/STROKEAHA.116.014852. Epub 2016 Nov 10.

    PMID: 27834743DERIVED

  • Menon BK, Sajobi TT, Zhang Y, Rempel JL, Shuaib A, Thornton J, Williams D, Roy D, Poppe AY, Jovin TG, Sapkota B, Baxter BW, Krings T, Silver FL, Frei DF, Fanale C, Tampieri D, Teitelbaum J, Lum C, Dowlatshahi D, Eesa M, Lowerison MW, Kamal NR, Demchuk AM, Hill MD, Goyal M. Analysis of Workflow and Time to Treatment on Thrombectomy Outcome in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) Randomized, Controlled Trial. Circulation. 2016 Jun 7;133(23):2279-86. doi: 10.1161/CIRCULATIONAHA.115.019983. Epub 2016 Apr 13.

    PMID: 27076599DERIVED

  • Al-Ajlan FS, Goyal M, Demchuk AM, Minhas P, Sabiq F, Assis Z, Willinsky R, Montanera WJ, Rempel JL, Shuaib A, Thornton J, Williams D, Roy D, Poppe AY, Jovin TG, Sapkota BL, Baxter BW, Krings T, Silver FL, Frei DF, Fanale C, Tampieri D, Teitelbaum J, Lum C, Dowlatshahi D, Shankar JJ, Barber PA, Hill MD, Menon BK; ESCAPE Trial Investigators. Intra-Arterial Therapy and Post-Treatment Infarct Volumes: Insights From the ESCAPE Randomized Controlled Trial. Stroke. 2016 Mar;47(3):777-81. doi: 10.1161/STROKEAHA.115.012424.

    PMID: 26892284DERIVED

  • Jacquin G, Oczkowski W. ACP Journal Club. In acute ischemic stroke, rapid intraarterial treatment plus usual care improved functional independence. Ann Intern Med. 2015 May 19;162(10):JC2-4. doi: 10.7326/ACPJC-2015-162-10-003. No abstract available.

    PMID: 25984876DERIVED

  • Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

    PMID: 25671798DERIVED

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic Agents

Study Officials

  • MIchael D Hill, MD MSc FRCPC

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Andrew M Demchuk, MD FRCPC

    University of Calgary

    STUDY DIRECTOR

  • Mayank Goyal, MD FRCPC

    University of Calgary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Clinical Neurosciences, Hotchkiss Brain Institute

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

CA(1)