Thrombectomy for Stroke

(ESCAPE-MeVO Trial)

Not currently recruiting at 57 trial locations

Overseen By Karla J Ryckborst, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Michael D Hill

Disqualifiers: Intracranial hemorrhage, Nursing home, Major co-morbid illness, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: Hospitalization period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if endovascular thrombectomy (EVT) can benefit individuals who have experienced a specific type of stroke caused by a blood clot in medium-sized brain vessels. Thrombectomy involves removing the clot to restore blood flow, potentially reducing disability or saving lives. Participants will receive either the best current stroke care or this care plus the thrombectomy procedure. This trial is suitable for those who have suffered a disabling stroke due to a clot in a medium-sized blood vessel and can reach the hospital within 12 hours of the stroke's onset. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance stroke treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the thrombectomy procedure is safe for treating medium vessel occlusion?

Research shows that endovascular thrombectomy (EVT) is generally safe for treating strokes caused by blocked blood vessels. Studies have found that many patients undergoing EVT experience successful restoration of blood flow to the brain. Specifically, a significant number achieve a good level of blood flow, indicating the treatment's effectiveness.

Regarding safety, EVT is linked to positive recovery outcomes and a low risk of serious issues like bleeding in the brain, suggesting the treatment is usually well-tolerated. Overall, evidence supports EVT as a safe option for treating sudden strokes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endovascular Thrombectomy (EVT) is unique because it directly removes the blood clot causing a stroke, rather than just breaking it down or managing symptoms like current treatments such as thrombolytic drugs. Unlike standard care options, EVT utilizes a specialized Solitaire device to physically extract the clot, potentially restoring blood flow more quickly and effectively. Researchers are excited about this technique because it offers the possibility of more immediate and substantial improvements in patients' recovery by directly addressing the blockage in the brain's blood vessels.

What evidence suggests that endovascular thrombectomy is effective for medium vessel occlusion stroke?

Research shows that endovascular thrombectomy (EVT), a procedure to remove blood clots from brain vessels, effectively treats ischemic strokes. In this trial, some participants will receive EVT, which studies have found leads to better recovery and less disability compared to using only medication. This is especially true for strokes caused by large clots in major blood vessels. Although less information exists about its use for clots in medium-sized vessels, EVT has succeeded in similar cases. The procedure restores blood flow and improves recovery chances. It has shown promising results in helping stroke patients regain function, making it a hopeful treatment option. ^{1 2 6 7 8}

Who Is on the Research Team?

Mayank Goyal, MD

Principal Investigator

University of Calgary and Foothills Medical Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke caused by a medium-sized blood clot in the brain, and can start treatment within 12 hours. They must have certain symptoms and imaging results that show they could benefit from EVT. People with severe other illnesses, those already in another trial, or with specific poor health indicators like low ASPECTS scores aren't eligible.

Inclusion Criteria

Time from onset (or last-seen-well) to randomization <12 hours

I have symptoms matching the area of my brain affected by a blockage.

I had a stroke that significantly affects my vision, speech, or hand use.

Exclusion Criteria

I live in a nursing home or need daily help with personal care.

There is a clear, light area in most of the brain where the blood vessel is blocked, or there are no backup blood vessels in that part of the brain.

You have a serious illness like severe memory loss, advanced cancer, or severe heart problems that may make it hard to finish the study or affect the main goal of the study because of the illness itself, not because of the stroke or its treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard of care or standard of care plus endovascular thrombectomy

Hospitalization period

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

1 visit (in-person) on Day 90

Long-term follow-up

Participants are monitored for long-term outcomes and quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Thrombectomy (EVT)

Trial Overview The ESCAPE-MeVO Trial is testing if adding endovascular thrombectomy (EVT) to standard medical care improves outcomes for patients with ischemic strokes due to medium vessel occlusions. Participants are randomly assigned to receive either just standard care or standard care plus EVT within 12 hours of symptom onset.

How Is the Trial Designed?

Group I: endovascular thrombectomy Experimental Treatment 1 Intervention

All participants will receive the best standard of medical care according to modern acute stroke care guidelines. In the intervention/experimental arm, participants will be treated with endovascular thrombectomy with a Solitaire device (Medtronic) as the first line approach. The trial mandates that the first attempt is performed with a Solitaire X device (3mm, 4mm or 6mm diameter devices; Medtronic). The remaining treatment technique is left to the discretion of the treating neurointerventionalist. Secondary devices may be used if success is not achieved after use of the first device.

Group II: best medical care Placebo Group 1 Intervention

All patients will receive the best standard of medical care according to modern acute stroke care guidelines All patients including the ones in control arm will receive the best standard of medical care according to modern acute stroke care guidelines. The model will be the Canadian best practices guidelines for acute stroke care. These are very similar to the guidelines of the American Stroke Association and the European Stroke Organization. All participants are expected to be admitted to hospital as part of routine standard of care.It is expected that all participants will undergo a routine work-up for the mechanism of their stroke and be treated appropriately and definitively.

Who Is Running the Clinical Trial?

Dr. Michael D Hill

Lead Sponsor

Trials

1

Recruited

530+

Dr. Michael Hill

Lead Sponsor

Trials

2

Recruited

680+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Endovascular thrombectomy significantly improved functional outcomes in patients with large ischemic strokes compared to medical care alone, with a generalized odds ratio of 1.51 indicating better recovery at 90 days.

While thrombectomy was effective, it was associated with some vascular complications, including arterial access-site issues and vessel perforations, but the rates of symptomatic intracranial hemorrhage were low in both treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Endovascular Thrombectomy for Large Ischemic Strokes. Sarraj, A., Hassan, AE., Abraham, MG., et al.[2023]

In a study of 94 patients with mild stroke syndromes and distal vessel occlusions, endovascular thrombectomy (EVT) showed similar rates of excellent and good outcomes compared to intravenous thrombolysis (IVT), with 75% and 70% achieving excellent outcomes respectively.

However, EVT was associated with a higher risk of intracranial bleeding (13.3% vs. 1.6% for IVT) and significantly higher mortality (13.3% vs. 1.6%), suggesting that while EVT can be effective, it carries increased safety risks that must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal arterial occlusions in patients with mild strokes - is endovascular therapy superior to thrombolysis alone? Nagel, S., Pfaff, J., Herweh, C., et al.[2020]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040531

Safety and Efficacy of Endovascular Thrombectomy for ... Favorable findings of short‐term functional outcomes demonstrate that EVT is likely an effective and acceptable treatment modality for patients ...

2. strokejournal.org strokejournal.org/article/S1052-3057(24)00651-7/fulltext

Endovascular thrombectomy for acute ischemic stroke with ... Primary outcomes were successful reperfusion (modified-Treatment in Cerebral Infarction (mTICI) score 2b-3), and favorable functional outcomes ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9631814/

Outcomes after endovascular thrombectomy for acute ... Patients with AC are less likely to have a favorable outcome and have a higher risk of mortality after EVT. Further studies are warranted for this unique ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666634025003162

Review Endovascular therapy for acute ischemic stroke Moreover, despite the robust efficacy of EVT demonstrated across multiple RCTs, overall outcomes remain suboptimal. In the HERMES meta ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214403

Trial of Endovascular Thrombectomy for Large Ischemic ... Endovascular thrombectomy has been shown to be more effective in reducing disability than medical therapy alone in selected patients with ischemic stroke.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37982851/

data from the Imperial College Thrombectomy Registry Our study suggests that EVT for LVO stroke in the elderly could be safe. The use of thromboaspiration was associated with positive reperfusion outcome in this ...

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00278-3/fulltext

Endovascular thrombectomy for acute ischaemic stroke ... The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025002992

Efficacy and Safety of Endovascular Thrombectomy for ... Specifically, patients who underwent EVT beyond 24 hours had a higher proportion of functional independence at 90 days and a lower risk of sICH. Therefore, EVT ...