Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE)

This study is not yet open for participant recruitment.
Verified December 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Collaborators:
University of Glasgow
University of Edinburgh
Newcastle University
Information provided by (Responsible Party):
Keith Muir, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01745692
First received: November 30, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Acute Ischaemic Stroke
Device: Mechanical thrombectomy
Drug: Intravenous rtPA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • modified Rankin Scale [ Time Frame: Day 90 +/-7 ] [ Designated as safety issue: No ]
    The proportion with favourable functional outcome defined as mRS 0-2 at 90 (+/-7) days based on the modified Rankin scale structured interview


Secondary Outcome Measures:
  • modified Rankin Scale [ Time Frame: Day 90+/-7 ] [ Designated as safety issue: No ]
    Full neurological recovery (mRS 0-1 versus 2-6)

  • Mortality [ Time Frame: Day 90 +/-7 ] [ Designated as safety issue: Yes ]
  • modified Rankin Scale [ Time Frame: Day 90 +/-7 ] [ Designated as safety issue: No ]
    Change in distribution of mRS scores adjusted for baseline variables

  • NIH Stroke Scale (NIHSS) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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)

  • Angiographic patency [ Time Frame: 22-36 hours ] [ Designated as safety issue: No ]
    Angiographic patency at 22-36 hours (Core lab assessed), using CTA or MRA

  • Immediate recanalisation rate [ Time Frame: End of procedure ] [ Designated as safety issue: No ]
    Immediate (i.e. end of procedure) recanalisation rates in subjects undergoing interventional procedures (core lab assessed).

  • Home Time [ Time Frame: Day 90 +/-7 ] [ Designated as safety issue: No ]
    Days spent at home between stroke and day 90

  • Symptomatic intracranial haemorrhage [ Time Frame: 22-26h ] [ Designated as safety issue: Yes ]
    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)

  • Intracranial haemorrhage [ Time Frame: 22-36 hours ] [ Designated as safety issue: Yes ]
    Any intracranial haemorrhage on 22-36h CT or MRI

  • Significant extracranial bleeding [ Time Frame: Up to day 90 ] [ Designated as safety issue: Yes ]
    Extracranial bleeding, groin haematoma requiring evacuation / surgery or transfusion


Estimated Enrollment: 800
Study Start Date: December 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous rtPA
IV alteplase (rtPA) 0.9mg/kg (10% of dose as bolus followed by 90% as infusion over 1 hour, to a maximum dose of 90mg total) given within 4.5 hours of onset of stroke symptoms
Drug: Intravenous rtPA
All patients receive IV alteplase
Other Name: alteplase
Experimental: Intravenous rtPA and Mechanical Thrombectomy
IV alteplase (rtPA) 0.9mg/kg (10% of dose as bolus followed by 90% as infusion over 1 hour, to a maximum dose of 90mg total) given within 4.5 hours of onset of stroke symptoms + additional mechanical thrombectomy procedure to commence within 90 minutes of start of IV rtPA infusion
Device: Mechanical thrombectomy Drug: Intravenous rtPA
All patients receive IV alteplase
Other Name: alteplase

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745692

Contacts
Contact: Keith W Muir, MD, FRCP 0141 201 2494 keith.muir@glasgow.ac.uk
Contact: Phil White, MD, FRCR

Locations
United Kingdom
NHS Greater Glasgow and Clyde Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Keith Muir, MBchB, MSc, MD, FRCP    0141 201 2494    keith.muir@glasgow.ac.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
University of Edinburgh
Newcastle University
Investigators
Principal Investigator: Keith W Muir, MD, FRCP University of Glasgow
  More Information

No publications provided

Responsible Party: Keith Muir, SINAPSE Professor of Clinical Imaging & Consultant Neurologist, University of Glasgow
ClinicalTrials.gov Identifier: NCT01745692     History of Changes
Other Study ID Numbers: GN11NE257, TSA 2011/06
Study First Received: November 30, 2012
Last Updated: December 7, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 23, 2014