Carotid Artery Stenting for Stroke

(EASI-TOC Trial)

Recruiting at 1 trial location

Overseen By Alexandre Y Poppe, MD CM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Antiplatelet therapy

Disqualifiers: Neurological impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

458 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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

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

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.

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?

Group I: Acute Stenting Active Control 2 Interventions

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.

Group II: No Acute Stenting Active Control 1 Intervention

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.

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:

• Symptomatic carotid stenosis
• Asymptomatic carotid stenosis

Approved in United States as Carotid artery stenting for:

• Symptomatic carotid stenosis
• High-risk asymptomatic carotid stenosis

Approved in Canada as Carotid artery stenting for:

• Symptomatic carotid stenosis
• Asymptomatic carotid stenosis

Approved in Japan as Carotid artery stenting for:

• Symptomatic carotid stenosis

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting. Bacharach, JM., Slovut, DP., Ricotta, J., et al.[2016]

Carotid artery stenting (CAS) has shown a low 30-day mortality rate of 0.9% and a stroke rate of 3-4% in recent case series, indicating improved safety compared to earlier studies.

Advancements in device technology and operator skills have led to a decrease in complication rates for CAS, suggesting that current outcomes may be better than those reported in older studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic review of complications for proper informed consent (9) periprocedural complications of carotid artery stenting: a review article]. Asai, T., Miyachi, S., Izumi, T., et al.[2018]

In a study of 25 high-risk surgical patients undergoing extracranial carotid artery stenting (CAS), only 2 patients experienced restenosis, indicating a low rate of this complication, particularly when post-stenting angioplasty was selectively applied.

The long-term morbidity and mortality rate was 8.3% for patients followed for at least two years, with no occurrences of serious complications like intracerebral hemorrhages or recurrent strokes, suggesting that CAS is a safe alternative for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracranial carotid artery stenting: the Puerto Rico medical center endovascular neurosurgery service experience. Feliciano, CE., Effio, E., Hernández-Gaitán, MS., et al.[2011]

In a study of 46,784 Medicare beneficiaries, the introduction of carotid arterial stenting (CAS) did not significantly reduce mortality or combined adverse outcomes compared to traditional carotid endarterectomy within 90 and 270 days after the procedure.

Higher adoption rates of CAS in certain localities were linked to increased rates of 90-day and 270-day adverse outcomes, suggesting that while CAS is an alternative treatment, it may carry higher risks in some settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of carotid arterial stenting versus endarterectomy. Groeneveld, PW., Yang, L., Greenhut, A., et al.[2021]

Carotid artery stenting (CAS) can be a safer alternative to carotid endarterectomy for certain patients, but it is important to identify specific anatomical and lesion characteristics that may increase the risk of complications during the procedure.

The paper aims to establish criteria for selecting patients who are most likely to benefit from CAS, highlighting the need for careful patient evaluation to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence overview: anatomical criteria determining patients at high risk for carotid stenting. VAN DEN Berg, JC.[2017]

Transradial carotid artery stenting (CAS) was successfully performed in 20 patients without any major complications, demonstrating its effectiveness as an alternative to the traditional transfemoral approach.

While the procedural and fluoroscopy times were slightly longer for transradial CAS compared to transfemoral CAS, the differences were minimal, suggesting that this technique can be a viable option for experienced operators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting the carotid artery from radial access using a Simmons guide catheter. Heck, D., Jost, A., Howard, G.[2022]

In a 9-year study involving 2,124 patients undergoing carotid artery stenting (CAS), the researchers developed the Siena CAS risk score to predict the 30-day risk of stroke based on various patient and procedural factors.

The Siena CAS score categorizes patients into low, medium, and high-risk groups for stroke, showing a sensitivity of 82% and specificity of 79%, but requires further validation before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Siena carotid artery stenting score: a risk modelling study for individual patients. Setacci, C., Chisci, E., Setacci, F., et al.[2022]

Carotid artery stenting (CAS) is a promising alternative to carotid endarterectomy (CEA) for high-risk patients, as illustrated by successful treatment of severe recurrent stenosis with a self-expanding stent.

Despite its potential, CAS is still in the early stages of development, and further trials are necessary to establish its long-term efficacy compared to CEA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of carotid artery stenosis. Cumming, ME., Cumming, MJ.[2016]

In a study of 10,958 Medicare patients aged 66 and older, carotid artery stenting (CAS) showed similar in-hospital and 1-year stroke rates compared to carotid endarterectomy (CEA), indicating comparable efficacy in preventing strokes.

However, CAS patients experienced significantly higher all-cause mortality at 1 year (9.9% for CAS vs. 6.1% for CEA), which may be attributed to their higher baseline risk factors, such as existing coronary and peripheral arterial disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after carotid artery stenting and endarterectomy in the Medicare population. Wang, FW., Esterbrooks, D., Kuo, YF., et al.[2018]

In a study of 61 patients undergoing carotid artery stenting (CAS) with embolic protection devices (EPDs), the selection of a proximal-occlusive-type EPD resulted in a low perioperative stroke rate of only 1.6% and no deaths, indicating its safety in high-risk patients.

The study suggests that using a tailored algorithm for EPD selection based on patient symptoms and imaging can effectively reduce major adverse events after CAS, highlighting the importance of personalized approaches in managing carotid artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative ischemic events in patients undergoing carotid artery stenting using algorithmic selection for embolic protection. Kawabata, Y., Nakajima, N., Miyake, H., et al.[2020]

Carotid artery stenting (CAS) is generally considered a safe treatment for internal carotid artery stenosis, but acute stent thrombosis can occur, posing serious risks, as demonstrated in a case involving a 79-year-old man who experienced this complication shortly after the procedure.

The successful management of acute stent thrombosis through a combination of thrombolysis and balloon postdilation highlights the importance of prompt intervention and suggests that mechanical approaches can effectively address complications when stents do not fully adhere to the blood vessel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute In-Stent Thrombosis after Carotid Angioplasty and Stenting: A Case Report and Literature Review. Hu, W., Wang, L., Wang, G.[2022]

In a study comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA) involving 94 patients (46 CAS and 48 CEA), both procedures showed similar rates of critical restenosis, stroke, and re-interventions over an average follow-up of 13 months.

The results suggest that CAS, when performed with neuroprotection devices, has comparable safety and efficacy to CEA, indicating it can be a viable alternative for treating carotid occlusive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up results of carotid angioplasty with stenting as assessed by duplex ultrasound surveillance. Park, B., Aiello, F., Dahn, M., et al.[2016]

Citations

1.

ahajournals.org

ahajournals.org/doi/10.1161/SVIN.124.001459

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11831615/

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 ...

3.

jacc.org

jacc.org/doi/10.1016/j.jcin.2024.03.014

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10318231/

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- ...

5.

eurointervention.pcronline.com

eurointervention.pcronline.com/article/thirty-day-outcomes-of-carotid-endarterectomy-versus-carotid-artery-stenting-in-asymptomatic-and-symptomatic-patients-a-propensity-score-matched-analysis

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.gov

pubmed.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 ...

7.

jwatch.org

jwatch.org/na57514/2024/06/18/real-world-data-safety-carotid-artery-stenting

Real-World Data on the Safety of Carotid Artery Stenting

Trials show that carotid artery stenting (CAS) is noninferior to carotid endarterectomy in patients with carotid artery stenosis.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1936879824005764

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.