458 Participants Needed

Carotid Artery Stenting for Stroke

(EASI-TOC Trial)

Recruiting at 1 trial location
NS
AY
Overseen ByAlexandre Y Poppe, MD CM
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

AY

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

You have a serious problem with your nerves that affects your daily life, as determined by you or your doctor.
I had a stroke and qualify for a clot removal procedure.
Informed consent from patient or surrogate or deferral of consent, according to local ethics policies
See 4 more

Exclusion Criteria

My neck artery is not severely narrowed or blocked, as confirmed by a specific imaging test.
You have a pre-existing neurological condition that affects your daily life.
I have a blockage in my neck artery but not in my brain.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo acute intracranial thrombectomy with or without ICA stenting

Immediate procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
Regular follow-up visits as per protocol

Long-term Follow-up

Participants are monitored for long-term outcomes and any recurrent stroke or retinal ischemia

1 year
Follow-up visits and assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Antiplatelet Agents
  • Carotid artery stenting
Trial Overview The EASI-TOC trial is testing if adding stenting (a procedure to keep arteries open) of the carotid artery improves recovery from stroke compared to just removing the brain clot without stenting. Participants will be randomly assigned either acute stenting plus clot removal or only clot removal.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Acute StentingActive Control2 Interventions
Group II: No Acute StentingActive Control1 Intervention

Carotid artery stenting is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Carotid artery stenting for:
🇺🇸
Approved in United States as Carotid artery stenting for:
🇨🇦
Approved in Canada as Carotid artery stenting for:
🇯🇵
Approved in Japan as Carotid artery stenting for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials
312
Recruited
112,000+

Health Sciences North Research Institute

Collaborator

Trials
11
Recruited
2,100+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+

McGill University

Collaborator

Trials
421
Recruited
1,017,000+

Laval University

Collaborator

Trials
439
Recruited
178,000+

Queen's University

Collaborator

Trials
382
Recruited
122,000+

University of Ottawa

Collaborator

Trials
231
Recruited
267,000+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+

Published Research Related to This Trial

In a study of 45 patients undergoing carotid artery stenting (CAS) from 2006 to 2018, the procedure showed a low minor stroke rate of 6.6% with no major strokes or deaths, indicating a favorable safety profile for high-risk patients.
The results suggest that CAS can be an effective treatment for carotid artery stenosis, especially in asymptomatic patients, and highlight the importance of centralizing the procedure to experienced interventionalists for optimal outcomes.
Results of carotid artery stenting. Lessons learned in a Belgian 'real world' practice.Kerselaers, L., Gallala, S., Aerden, D., et al.[2022]
In a study of 96 patients undergoing carotid artery stenting (CAS), those with open-cell stents experienced significantly more new lesions on postprocedural imaging compared to those with closed-cell stents (24 vs 12 lesions).
While the overall 30-day clinical outcomes were similar between the two stent types, stent design was identified as a strong risk factor for new embolism, suggesting that choosing the right stent could enhance patient outcomes.
Incidence of embolism associated with carotid artery stenting: open-cell versus closed-cell stents.Park, KY., Kim, DI., Kim, BM., et al.[2022]
In a study of 224 patients undergoing carotid angioplasty and stenting (CAS), octogenarians (patients aged 80 and above) did not experience a higher risk of adverse events compared to younger patients, indicating that age alone should not exclude patients from this procedure.
Both groups had similar procedural success rates and hospital stays, with low rates of transient ischemic attacks and strokes, suggesting that CAS is a safe option for older patients when performed under appropriate conditions.
Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting.Bacharach, JM., Slovut, DP., Ricotta, J., et al.[2016]

Citations

Carotid Artery Stenting Outcomes by Neurointerventional ...Studies show a higher 30‐day mortality rate among operators with low annual procedure volumes and experience. CAS remains a skill‐demanding ...
Carotid Artery Stenting during Endovascular treatment ...Secondary outcomes include excellent (mRS 0–1) and good (mRS 0–2) functional outcome at 90 days, stroke severity measured with the National ...
Real-World Outcomes of Carotid Artery Stenting in ...The primary outcome was the incidence of ischemic stroke or all-cause death at 30 days after CAS. Secondary outcomes were the incidences of ...
Long-term outcomes of carotid artery stenting in patients ...International Carotid Stenting Study (ICSS) has compared outcomes of a total 1,713 carotid artery stenosis patients with a median follow-up of 4.2 years. The 5- ...
Thirty-day outcomes of carotid endarterectomy versus ...CONCLUSIONS: Propensity-matched analysis suggests that CAS has similar postprocedural outcomes for stroke, AMI and death at 30 days compared to CEA.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36857054/
Functional and Safety Outcomes of Carotid Artery Stenting ...Objective: To evaluate the association of carotid artery stenting (CAS) vs no stenting and medical management with functional and safety ...
Real-World Data on the Safety of Carotid Artery StentingTrials show that carotid artery stenting (CAS) is noninferior to carotid endarterectomy in patients with carotid artery stenosis.
Real-World Outcomes of Carotid Artery Stenting in ...The purpose of this study was to investigate the real-world clinical outcomes of CAS in symptomatic and asymptomatic patients with carotid artery stenosis.
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