Ischemic StrokePhase 3ESCAPENCT01778335

Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke

A Phase 3 study testing Endovascular thrombectomy/thrombolysis in people with Ischemic Stroke, run by University of Calgary at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: Endovascular thrombectomy/thrombolysis
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 316 participants
Where: 1 siteCanada
Study dates: Jan 2013to Jan 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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).

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Calgary
Calgary, Alberta, T2N2T9

Other trials in Canada

About this study

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

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.

Read the detailed description

ESCAPE is a phase 3, randomized, open-label with blinded outcome evaluation, controlled, parallel group design.

The primary objectives of this study are to show that rapid endovascular revascularization amongst radiologically selected (small core/proximal occlusion) patients with ischemic stroke results in improved outcome compared to patients treated in clinical routine.

Eligible patients will be enrolled within 12 hours of last seen normal with a baseline NIHSS > 5 at the time of randomization. There must be a 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.

All patients will receive the best standard of medical care according to modern acute stroke care guidelines. Control arm subjects will receive best medical care. In the intervention/experimental arm, subjects will be treated with endovascular thrombectomy or thrombolysis using currently available technology for use in the ESCAPE site for thrombectomy/thrombolysis.

This study consists of one 90-day study period for each subject. Subjects will be hospitalized for care after their acute stroke according to the current standard of care. Subjects are required to return to clinic on Days 30 \& 90 for end-of-study procedures.

Conditions: Ischemic Stroke
Being tested: Endovascular thrombectomy/thrombolysis
Keywords: recanalization, endovascular, thrombectomy
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endovascular thrombectomy/thrombolysisProcedure or surgery
Also called Endovascular mechanical thrombectomy
Endovascular mechanical thrombectomy or thrombolysis

Study groups in NCT01778335
Study group	Role	What they receive
Control	No intervention	Control arm subjects will receive best medical care.
Endovascular thrombectomy/thrombolysis	Experimental	Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent Receives: Procedure: Endovascular thrombectomy/thrombolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Shift in the mRS score, defined by a proportional odds model.
Measured: 90 days

Secondary outcomes (8)

The proportion of patients who achieve a NIHSS score 0-2
Stroke severity. Clinical scale outcome score from 0 to 42.
Measured: 90 days
The proportion of patients who achieve a mRS 0-2
Functional outcome. Dichotomous outcome, reported as independent (mRS 0-2) vs dependence or death (mRS 3-6). In addition, shift analysis (proportional odds model) representing the odds of improvement on within the scale with treatment.
Measured: 90 days
The proportion of patients who achieve a Barthel Index > 90
Activities of daily living. Clinical scale outcome score from 0 to 100.
Measured: 90 days
EQ5D
Quality of life. Clinical scale score as well as a visual analog scale of QOL from 0 to 100.
Measured: 90 days
Cognitive outcome - Trailmaking A, B
Trailmaking A, B; Executive function task. Timed outcome as a continuous measure in seconds.
Measured: 90 days
Cognitive outcome - MOCA
Global test of cognitive function. Scale from 0 to 30 points.
Measured: 90 days
Cognitive outcome - Boston Naming Test
Test of language function
Measured: 90 days
Cognitive Outcome - Sunnybrook hemi-spatial neglect battery
Test of hemi-spatial neglect.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jan 2015

First posted29 Jan 2013 (estimated)
Study startJan 2013
Primary completionNov 2014
Study completionJan 2015

Why it stopped: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
More trials run by University of CalgaryThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01778335
Sponsor's protocol ID: Version 3.8
Acronym: ESCAPE
Status last verified: Mar 2015
First submitted: 25 Jan 2013
Last updated: 23 Mar 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 34824139
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.
PubMed 33431075
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.
PubMed 33213288
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.
PubMed 32515694
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.
PubMed 30045949
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.
PubMed 29203689
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.
PubMed 29191873
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.
PubMed 29096678
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.
PubMed 29021311
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.
PubMed 27924049
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.
PubMed 27834743
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.
PubMed 27076599
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.
PubMed 26892284
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.
PubMed 25984876
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.
PubMed 25671798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
ClinicalTrials.gov ID: NCT01778335
Acronym / sponsor ID: ESCAPE / Version 3.8
Conditions: Ischemic Stroke
Keywords: recanalization, endovascular, thrombectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.
Enrolment: 316 participants (actual)
Lead sponsor: University of CalgaryUniversity, hospital or other
Collaborators: Medtronic - MITG, Heart and Stroke Foundation of Canada, Hotchkiss Brain Institute, University of Calgary
Study start: Jan 2013
Primary completion: Nov 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.

Detailed description

ESCAPE is a phase 3, randomized, open-label with blinded outcome evaluation, controlled, parallel group design.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Control arm subjects will receive best medical care.
Endovascular thrombectomy/thrombolysis	Experimental	Procedure: Endovascular thrombectomy/thrombolysisEndovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (12 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endovascular thrombectomy/thrombolysisAlso: Endovascular mechanical thrombectomyEndovascular mechanical thrombectomy or thrombolysis	Procedure or surgery	Endovascular thrombectomy/thrombolysis

Primary outcome

Shift in the mRS score, defined by a proportional odds model.
Time frame: 90 days

8 secondary outcomes

The proportion of patients who achieve a NIHSS score 0-2
Time frame: 90 days
The proportion of patients who achieve a mRS 0-2
Time frame: 90 days
The proportion of patients who achieve a Barthel Index > 90
Time frame: 90 days
EQ5D
Time frame: 90 days
Cognitive outcome - Trailmaking A, B
Time frame: 90 days
Cognitive outcome - MOCA
Time frame: 90 days
Cognitive outcome - Boston Naming Test
Time frame: 90 days
Cognitive Outcome - Sunnybrook hemi-spatial neglect battery
Time frame: 90 days

Results and safety

The study was stopped early (reason given: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Derived from this study: PubMed 34824139Rajashekar 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.
Derived from this study: PubMed 33431075Sevick 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.
Derived from this study: PubMed 33213288Ospel 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.
Derived from this study: PubMed 32515694Ganesh 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.
Derived from this study: PubMed 30045949Kaneko 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.
Derived from this study: PubMed 29203689Brigdan 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.
Derived from this study: PubMed 29191873Evans 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.
Derived from this study: PubMed 29096678Sajobi 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.
Derived from this study: PubMed 29021311Assis 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.
Derived from this study: PubMed 27924049Sajobi 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.
Derived from this study: PubMed 27834743Ganesh 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.
Derived from this study: PubMed 27076599Menon 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.
ESCAPE siteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MIchael D Hill, MD MSc FRCPC principal investigator

University of Calgary

Andrew M Demchuk, MD FRCPC study director

University of Calgary

Mayank Goyal, MD FRCPC study director

University of Calgary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endovascular thrombectomy/thrombolysis in people with Ischemic Stroke, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shift in the mRS score, defined by a proportional odds model. (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01778335, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.