title: Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times (ESCAPE) trial: methodology.
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.
authors.affiliation: Departments of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Demchuk
authors.forename: Mayank
authors.initials: M
authors.lastname: Goyal
authors.forename: Bijoy K
authors.initials: BK
authors.lastname: Menon
authors.forename: Muneer
authors.initials: M
authors.lastname: Eesa
authors.forename: Karla J
authors.initials: KJ
authors.lastname: Ryckborst
authors.forename: Noreen
authors.initials: N
authors.lastname: Kamal
authors.forename: Shivanand
authors.initials: S
authors.lastname: Patil
authors.forename: Sachin
authors.initials: S
authors.lastname: Mishra
authors.forename: Mohammed
authors.initials: M
authors.lastname: Almekhlafi
authors.forename: Privia A
authors.initials: PA
authors.lastname: Randhawa
authors.forename: Daniel
authors.initials: D
authors.lastname: Roy
authors.forename: Robert
authors.initials: R
authors.lastname: Willinsky
authors.forename: Walter
authors.initials: W
authors.lastname: Montanera
authors.forename: Frank L
authors.initials: FL
authors.lastname: Silver
authors.forename: Ashfaq
authors.initials: A
authors.lastname: Shuaib
authors.forename: Jeremy
authors.initials: J
authors.lastname: Rempel
authors.forename: Tudor
authors.initials: T
authors.lastname: Jovin
authors.forename: Donald
authors.initials: D
authors.lastname: Frei
authors.forename: Biggya
authors.initials: B
authors.lastname: Sapkota
authors.forename: J Michael
authors.initials: JM
authors.lastname: Thornton
authors.forename: Alexandre
authors.initials: A
authors.lastname: Poppe
authors.forename: Donatella
authors.initials: D
authors.lastname: Tampieri
authors.forename: Cheemun
authors.initials: C
authors.lastname: Lum
authors.forename: Alain
authors.initials: A
authors.lastname: Weill
authors.forename: Tolulope T
authors.initials: TT
authors.lastname: Sajobi
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020521:Stroke / Q000628:therapy*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: CT-angiography; acute stroke therapy; clinical trial; collaterals; endovascular treatment; reperfusion