Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke

Ischemic Stroke Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01778335
• Other study ID #: Version 3.8
• Status: Terminated
• Phase: Phase 3
• First received: January 25, 2013
• Last updated: March 20, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 316
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria A. Clinical (Heterogeneous sampling frame)

1. Acute ischemic stroke

2. Age 18 or greater

3. Onset (last-seen-well) time to randomization time < 12 hours.

4. Disabling stroke defined as a baseline NIHSS > 5 at the time of randomization.

5. 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)

6. 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.

7. Non-contrast CT and CTA for trial eligibility performed or repeated at ESCAPE stroke center with endovascular suite on-site.

8. 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.

9. Signed informed consent or appropriate signed deferral of consent where approved.

Exclusion Criteria

1. 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.

2. Other confirmation of a moderate to large core defined one of three ways:

1. 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

2. On CT perfusion (>8 cm coverage): a low CBV and very low CBF ASPECTS <6 AND in the symptomatic MCA territory OR

3. On CT perfusion(<8 cm coverage): a region of low CBV and very low CBF >1/3 of the CTP imaged symptomatic MCA territory.

3. 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).

4. 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.

5. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.

6. Severe contrast allergy or absolute contraindication to iodinated contrast.

7. Suspected intracranial dissection as a cause of stroke.

8. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.

9. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Endovascular thrombectomy/thrombolysis
Endovascular mechanical thrombectomy or thrombolysis

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Heart and Stroke Foundation of Canada, Hotchkiss Brain Institute, University of Calgary, Medtronic - MITG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients who suffer a Safety Outcome	The proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to femoral artery access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy.	0-90 days	Yes
Other	Economic (cost-effectiveness) analysis	Economic analysis	90 days	No
Other	Evaluation of waiver/deferral of consent process	Qualitative evaluation of the waiver/deferral of consent process	90 days	Yes
Other	Safety - Other	(i) The total radiation dose (CT, CTA, angiography) reported as a continuous measure.; (ii) The proportion of patients with malignant MCA infarction (iii) The proportion of patients undergoing hemicraniectomy.	90 days	Yes
Primary	Shift in the mRS score, defined by a proportional odds model.		90 days	No
Secondary	The proportion of patients who achieve a NIHSS score 0-2	Stroke severity. Clinical scale outcome score from 0 to 42.	90 days	No
Secondary	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.	90 days	No
Secondary	The proportion of patients who achieve a Barthel Index > 90	Activities of daily living. Clinical scale outcome score from 0 to 100.	90 days	No
Secondary	EQ5D	Quality of life. Clinical scale score as well as a visual analog scale of QOL from 0 to 100.	90 days	No
Secondary	Cognitive outcome - Trailmaking A, B	Trailmaking A, B; Executive function task. Timed outcome as a continuous measure in seconds.	90 days	No
Secondary	Cognitive outcome - MOCA	Global test of cognitive function. Scale from 0 to 30 points.	90 days	No
Secondary	Cognitive outcome - Boston Naming Test	Test of language function	90 days	No
Secondary	Cognitive Outcome - Sunnybrook hemi-spatial neglect battery	Test of hemi-spatial neglect.	90 days	No

External Links

•   ESCAPE site