Pragmatic Ischaemic Stroke Thrombectomy Evaluation

Acute Ischaemic Stroke Clinical Trial

— PISTE  

Official title:

A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared With Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke Due to an Occluded Major Intracranial Vessel.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01745692
• Other study ID #: GN11NE257
• Secondary ID: TSA 2011/06
• Status: Terminated
• Phase: N/A
• First received: November 30, 2012
• Last updated: October 23, 2015
• Start date: December 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of supratentorial acute ischaemic stroke

• Male or nonpregnant female =18 years of age

• Clinically significant neurological deficit and NIHSS score =6.

• Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset.

• Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset).

• Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA.

• Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke.

• Consent of patient or representative.

• Independent prior to the stroke (estimated mRS 02)

• Expected to be able to be followed up at 3 months

Exclusion Criteria:

• CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT.

• Clinical history suggestive of subarachnoid haemorrhage even if CT normal.

• Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible.

• Extracranial ICA occlusion or basilar artery occlusion

• Alternative intracranial pathology potentially responsible for the new symptoms

• 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)

• Known allergy to radiological contrast

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischaemic Stroke
• Ischemia
• Stroke

Intervention

Device:
• Mechanical thrombectomy

Drug:
• Intravenous rtPA
All patients receive IV alteplase

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (4)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Newcastle University, University of Edinburgh, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	The proportion with favourable functional outcome defined as mRS 0-2 at 90 (+/-7) days based on the modified Rankin scale structured interview	Day 90 +/-7	No
Secondary	modified Rankin Scale	Full neurological recovery (mRS 0-1 versus 2-6)	Day 90+/-7	No
Secondary	Mortality		Day 90 +/-7	Yes
Secondary	modified Rankin Scale	Change in distribution of mRS scores adjusted for baseline variables	Day 90 +/-7	No
Secondary	NIH Stroke Scale (NIHSS)	Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1, at 72 hours (or discharge if earlier)	72 hours	No
Secondary	Angiographic patency	Angiographic patency at 22-36 hours (Core lab assessed), using CTA or MRA	22-36 hours	No
Secondary	Immediate recanalisation rate	Immediate (i.e. end of procedure) recanalisation rates in subjects undergoing interventional procedures (core lab assessed).	End of procedure	No
Secondary	Home Time	Days spent at home between stroke and day 90	Day 90 +/-7	No
Secondary	Symptomatic intracranial haemorrhage	Symptomatic intracranial haemorrhage rates defined as local or remote parenchymal haemorrhage type 2 (PH2 or PHr2 ICH by ECASS 2 definition) on the 22-36 h post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death (SITS-MOST definition)	22-26h	Yes
Secondary	Intracranial haemorrhage	Any intracranial haemorrhage on 22-36h CT or MRI	22-36 hours	Yes
Secondary	Significant extracranial bleeding	Extracranial bleeding, groin haematoma requiring evacuation / surgery or transfusion	Up to day 90	Yes