Pragmatic Ischaemic Stroke Thrombectomy Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

NCT03144960

Acute Stroke

UNKNOWN NA

Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion

NCT06427187

Acute Ischemic Stroke

NOT_YET_RECRUITING NA

Thrombectomy in Patients Ineligible for iv tPA

NCT02135926

Ischemic Stroke

TERMINATED NA

Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion

NCT05030142

Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

UNKNOWN NA

A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT

NCT00789542

Stroke

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischaemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Intravenous rtPA

Intervention Type DRUG

All patients receive IV alteplase

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

Group Type EXPERIMENTAL

Mechanical thrombectomy

Intervention Type DEVICE

Intravenous rtPA

Intervention Type DRUG

All patients receive IV alteplase

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mechanical thrombectomy

Intervention Type DEVICE

Intravenous rtPA

All patients receive IV alteplase

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

alteplase

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No