Stroke: an evaluation of thrombectomy in the ageing brain version 1 (STABILISE)

Completed

• Conditions: Topic: Stroke; Subtopic: Acute Care; Disease: Device used; Circulatory System

• Registration Number: ISRCTN15698516
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-09
• Last Update Posted: 26 March 2018
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Clinical diagnosis of acute ischaemic stroke
2. Male or nonpregnant female at least 50 years of age
3. Clinically significant neurological deficit and NIHSS score 10 or greater
4. Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of theimaging (CT/CTA) confirmed diagnosis of LVO (AND maximum 5h after stroke onset anterior circulation, 8.5h for posterior circulation).
5. Occlusion of the MCA trunk, MCA bifurcation or intracranial internal carotid artery (including carotidT),M1 or =2 proximal M2 branches; intracranial vertebral/basilar/P1 PCA demonstrated on CTA, MRA, or DSA
6. Interventional device delivery (guide catheter placed in target artery beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke (9h for posterior circulation occlusions)
7. Consent of patient or assent of appropriate representative
8. Independent prior to the stroke (estimated mRS 02)
9. Expected to be able to be followed up at 12 months

Exclusion Criteria

1. CT evidence of ICH, or evidence of extensive established hypodensity on CT(defined as >1/3 MCA territory orASPECTS score =7). In posterior circulation strokes pcASPECTS <7 or >1/3 of territory
2. Clinical history suggestive of subarachnoid haemorrhage even if CT normal.
3. Eligible for an academic treatment policy” (i.e. phase III trial) RCT of stroke thrombectomy in that institution & willing to be randomised into such
4. Vascular access contraindications e.g. bilateral femoral bypass surgery, tight ipsilateral carotid or vertebral stenosis (if judged not readily amenable to acute intervention by Interventional Neuroradiologist [INR] who would carry out the
procedure), unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult, unsafe or impossible (as judged by INR who would carry out the procedure)
5. Extracranial: chronic/atherosclerotic ipsilateral ICA or dominant vertebral artery occlusion
6. Alternative intracranial pathology potentially responsible for the new symptoms
7. Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy)
8. Known allergy to radiological contrast
9. Absolute contraindication to MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of novel thrombectomy device, based on the angiographic run at the end of the procedure

Secondary Outcome Measures

Name	Time	Method
1. Safety – intracranial haemorrhage at 24 hours, others will be throughout the follow up period<br>2. Feasibility – at day 1, 90 and 180<br>3. Neurological recovery – mRS at day 90 and 365<br>4. Early major neurological improvement – at 72 hours<br>5. Sustained recanalization – 24h<br>6. Days spent at home – 90 days<br>7. Mortality – 365 days<br>8. Collateral score on CTA & clinical outcome – 365 days<br>9. MRI marker of procedural risk – 24 hours