Carotid Artery Stenting for Stroke
(EASI-TOC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding a stent (a small tube) to open blocked arteries during a stroke procedure improves recovery compared to the procedure alone. It focuses on individuals experiencing a stroke due to blockages in both the brain's blood vessels and the neck's carotid artery. Participants should have a sudden, severe stroke affecting the brain's main arteries and a significant blockage in the neck's carotid artery. The trial compares patients receiving standard stroke care with a stent (carotid artery stenting) to those receiving standard care without a stent. As an unphased trial, this study allows participants to contribute to important research that could enhance stroke recovery treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known contra-indication to antiplatelet therapy, you may not be eligible to participate.
What prior data suggests that carotid artery stenting is safe for stroke patients?
A previous study showed that carotid artery stenting (CAS) is as safe as carotid endarterectomy, another common treatment for narrowing of the carotid arteries. Research indicates that the safety of CAS depends on the doctor's experience. With more practice, doctors tend to achieve better outcomes with CAS.
Real-world data suggests that CAS is generally well-tolerated in both symptomatic and asymptomatic patients. However, it's important to remember that, like any medical procedure, CAS can still carry risks. Some studies have found a higher risk of complications with less experienced doctors.
Overall, while carotid artery stenting appears to be a safe option for many patients, the skill and experience of the medical team play a significant role in ensuring the best outcomes.12345Why are researchers excited about this trial?
Carotid artery stenting for stroke is unique because it offers a way to re-open narrowed carotid arteries by placing a stent during the acute thrombectomy procedure. Unlike the standard of care that typically involves just thrombectomy and intravenous thrombolysis, this approach directly addresses cervical carotid artery stenosis at the same time. Researchers are excited because this could potentially reduce the risk of recurrent strokes by ensuring better blood flow immediately, rather than waiting for a separate procedure to address the stenosis.
What evidence suggests that carotid artery stenting might be an effective treatment for stroke?
In this trial, some participants will receive carotid artery stenting during the acute thrombectomy procedure, while others will not. Research has shown that using stents in the carotid artery can aid stroke recovery. Studies have found that patients receiving stents during procedures to open blocked blood vessels often recover better after 90 days, enabling them to perform daily activities with little or no assistance. The International Carotid Stenting Study found that stenting is as safe and effective as other common procedures, like carotid endarterectomy, within the first 30 days. Although high-quality trial data remains limited, these findings suggest that stenting could be a promising treatment for stroke patients with severe artery blockages.25678
Who Is on the Research Team?
Alexandre Y Poppe, MD CM
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
This trial is for stroke patients with a specific blockage in the neck arteries (carotid artery disease) and an additional clot in the brain, who can get to the hospital within 24 hours of symptoms starting. They must be able to give consent and have a chance of recovery with treatment. Pregnant individuals, those unlikely to follow the study plan or attend follow-up, or with certain pre-existing conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo acute intracranial thrombectomy with or without ICA stenting
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes and any recurrent stroke or retinal ischemia
What Are the Treatments Tested in This Trial?
Interventions
- Antiplatelet Agents
- Carotid artery stenting
Carotid artery stenting is already approved in European Union, United States, Canada, Japan for the following indications:
- Symptomatic carotid stenosis
- Asymptomatic carotid stenosis
- Symptomatic carotid stenosis
- High-risk asymptomatic carotid stenosis
- Symptomatic carotid stenosis
- Asymptomatic carotid stenosis
- Symptomatic carotid stenosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Queen's University
Collaborator
Kingston Health Sciences Centre
Collaborator
Health Sciences North Research Institute
Collaborator
University of Alberta
Collaborator
McGill University
Collaborator
Laval University
Collaborator
Queen's University
Collaborator
University of Ottawa
Collaborator
McMaster University
Collaborator