Condition category
Circulatory System
Date applied
08/01/2015
Date assigned
09/01/2015
Last edited
08/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech difficulties. They can often be treated with a “clotbusting” (“thrombolytic”) drug. However, a “clotbusting” drug is less likely to open the blocked blood vessel if the clot is larger and some people have medical conditions that mean it is not safe to give them a clot busting drug. Medical devices that can remove clots (clot pullers or retrievers) may be used as an additional treatment to thrombolysis or instead of no active treatment where thrombolysis cannot safely be given. The procedure is called thrombectomy. Such devices are more likely to open up the blocked blood vessel, but are more complicated to use. We are doing a study to investigate whether treatment using a purpose designed new clot retrieval device is at least as safe and effective in unblocking the occluded blood vessel after an acute stroke as existing devices. The new device has design features that may be particularly useful in elderly patients. We will investigate whether additional brain imaging would be helpful in acute stroke patients treated with clot pullers by:
1) Examining whether analysis of blood vessels on the scans taken before treatment starts can predict who will or will not do well, and see if there is any link to age.
2) Detailed MRI brain scan 24h after treatment to see if scan findings at that stage can predict long term outcome, identify complications not appreciated on routine CT and see whether these are linked to patient age.

Who can participate?
Adults aged at least 50 diagnosed with a stroke caused by a blocked artery (acute ischaemic stroke).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have a thrombectomy. Performed using the new device. Those in group 2 have a thrombectomy performed using the standard device. The safety and efficacy of the novel thrombectomy device is assessed after the procedure. All participants have a MRI brain scan 24 hours after treatment.

What are the possible benefits and risks of participating?
The study population has a high risk of adverse events as a direct consequence of the condition being treated . All patients undergo standard best medical therapy for them, including where indicated, IV thrombolysis as well as thrombectomy and none of the risks/discomfort/inconvenience possible from these are related to participation in the study. The main inconvenience/intrusion comes from approaching the patient, or more likely a relative, about participation in a research study at a time of natural concern and anxiety following major stroke. However, all teams involved in the study will be accustomed to recruiting patients into hyperacute research studies, including one involving thrombectomy (PISTE or similar) and will have appropriate experience and training for this role. Patient/Consultee information sheets including a short summary sheet and an introductory 1 page information sheet will be available to assist a sensitive, informed approach.

Where is the study run from?
Institute for Ageing and Health, Newcastle upon Tyne (UK)

When is the study starting and how long is it expected to run for?
November 2014 to November 2016

Who is funding the study?
Biomedical Research Centre (UK)

Who is the main contact?
Dr Adela Cora

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elena Adela Cora

ORCID ID

Contact details

Institute for Ageing and Health
3-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17942

Study information

Scientific title

Stroke: an evaluation of Thrombectomy in the Ageing Brain [including] where IV thromboLysis fails or is contraindicated.

Acronym

STABILISE

Study hypothesis

We are doing a study to investigate whether treatment using a purpose designed new clot retrieval device is at least as safe and effective in unblocking the occluded blood vessel after an acute ischaemic stroke as existing devices. The new device has design features that may be particularly useful in elderly patients with more difficult vascular access.
We will investigate whether additional brain imaging would be helpful in acute stroke patients treated with clot retrieval by:
1. Examining whether analysis of blood vessels on the scans taken before treatment starts can predict who will or will not do well, and see if there is any link to age.
2. Detailed MRI brain scan 24h after treatment to see if scan findings at that stage can predict long term outcome, identify complications not appreciated on routine CT and see whether these are linked to patient age.

Ethics approval

NRES Committee North East – Newcastle & North Tyneside, 04/07/2014, ref: 14/NE/0113

Study design

Randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Stroke; Subtopic: Acute Care; Disease: Device used

Intervention

Thrombectomy performed via randomisation with standard or new device

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Safety and efficacy of novel thrombectomy device. This will be based on the angiographic run at the end of the procedure.

Secondary outcome measures

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

Overall trial start date

01/11/2014

Overall trial end date

30/11/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant 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

Recruitment start date

01/11/2014

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Ageing and Health
3-4 Claremont Terrace Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Biomedical Research Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes