Study of intra-arterial alteplase (t-PA) during mechanical thrombectomy treatment in patients with acute ischemic stroke caused by large vessel blockage

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What is this study about?

This study focuses on patients with acute ischemic stroke, a condition where blood flow to the brain is blocked by a clot in one of the major blood vessels. The study examines the effectiveness of using alteplase (also known as t-PA), a clot-dissolving medication, during a procedure called mechanical thrombectomy where doctors physically remove the blood clot that is blocking blood flow to the brain.

The purpose of this research is to determine whether giving alteplase directly into the affected artery during mechanical thrombectomy can improve outcomes for stroke patients. The medication will be given through intraarterial injection, which means it is delivered directly into the blocked blood vessel while doctors are removing the clot.

During the study, participants will receive the standard mechanical thrombectomy procedure to remove the blood clot, with some patients also receiving alteplase through the artery. The treatment is given as a single dose during the procedure, and patients will be monitored afterward to assess their recovery from the stroke. The study will track how well patients recover their ability to perform daily activities and whether they experience any complications.

1 Initial assessment

Your eligibility for the study will be evaluated if you have experienced an acute ischemic stroke affecting large blood vessels in the brain

You must be at least 18 years old and have significant stroke symptoms with a specific severity score of 6 or higher

Brain imaging will be performed to confirm the location of the blood clot and measure the affected brain tissue

2 Treatment procedure

The procedure must begin within 9 hours from the start of stroke symptoms

You will receive mechanical thrombectomy – a procedure to remove the blood clot from your brain

During the procedure, you may receive Actilyse (alteplase) medication directly into the affected artery

3 Monitoring period – first 48 hours

Your condition will be closely monitored for the first 24-48 hours after the procedure

A brain scan will be performed to check for any bleeding complications

Your kidney function will be monitored to check for any effects of the contrast dye used during the procedure

4 Recovery assessment

Your recovery progress will be evaluated using specific medical scales

The medical team will assess your ability to perform daily activities

Your overall recovery and any complications will be documented

5 Final evaluation

The medical team will determine if you can be discharged home, with or without additional support services

Your final recovery status will be assessed using standardized scales

Any complications or adverse events during the study period will be recorded

Who Can Join the Study?

Must be able to provide informed consent by signature or oral consent followed by signature
Must be at least 18 years old
Must have a significant neurological deficit with a NIHSS score of 6 or higher (NIHSS is a scale that measures stroke severity)
Must have been independent in daily activities before the stroke (modified Rankin Scale score of 1 or less)
Must be eligible for blood vessel treatment (endovascular treatment)
Must arrive within 9 hours of stroke symptoms starting, or if symptoms were noticed upon waking up, the time will be calculated from the midpoint between going to sleep and waking up
Must have a complete blockage in either the internal carotid artery or middle cerebral artery (main blood vessels in the brain) that can be treated with mechanical removal
Must have an area of brain damage that is 70 milliliters or less in size, as measured by special brain scans
Must have an area of brain tissue that could potentially be saved (called penumbra), which is at least 20% larger than the damaged area and differs by at least 10 milliliters in size
If coming from another hospital, the clot-dissolving medication (tPA) must have been completed at least 40 minutes before a confirming CT scan

Who Cannot Join the Study?

Age below 18 years or above 85 years
Pregnancy or breastfeeding women
Previous stroke in the last 3 months
Active internal bleeding
Known bleeding disorder or blood clotting problems
Use of blood thinners (anticoagulant medications) in the past 48 hours
Severe head trauma or brain surgery in the past 3 months
Current brain tumor or known brain abnormalities
Blood pressure above 185/110 mmHg that cannot be controlled with medication
Blood sugar level below 50 mg/dL or above 400 mg/dL
Major surgery in the past 14 days
Current participation in other clinical trials
Unable to provide informed consent (either directly or through a legal representative)
Life expectancy less than 90 days due to other medical conditions
Severe kidney or liver disease

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Htuzqkil Vxyx dwucwaux	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	31.05.2024

Trial locations

Investigated drugs:

Alteplase

Tissue Plasminogen Activator (tPA) is a medication that helps dissolve blood clots. In this trial, it is administered directly into the arteries during mechanical thrombectomy. It works by converting plasminogen to plasmin, which breaks down blood clots that are blocking blood flow to the brain during an acute stroke.

Mechanical thrombectomy is not a medication but a surgical procedure where doctors use special devices to physically remove blood clots from blocked arteries in the brain. This procedure is performed by threading a catheter through blood vessels to reach and remove the clot that is causing the stroke.

Investigated diseases:

Ischaemic stroke

Acute Ischemic Stroke – A condition that occurs when blood flow to the brain is suddenly blocked by a clot in one of the large blood vessels of the anterior (front) part of the brain. This blockage prevents oxygen and nutrients from reaching brain tissue, leading to the death of brain cells in the affected area. The condition typically develops suddenly and causes symptoms such as weakness or paralysis on one side of the body, difficulty speaking, and facial drooping. Acute ischemic stroke specifically involving large vessel occlusion affects the major arteries of the brain, potentially impacting a significant portion of brain tissue. The severity of symptoms depends on which area of the brain is affected and how long the blockage persists.

Trial ID:

2023-510374-13-00

Protocol code:

Vanish Trial

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of intra-arterial alteplase (t-PA) during mechanical thrombectomy treatment in patients with acute ischemic stroke caused by large vessel blockage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?