Thrombectomy for Stroke

(ESCAPE-MeVO Trial)

Recruiting at 54 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

530 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether removing blood clots from medium-sized brain vessels helps stroke patients. The procedure uses a special device to pull out the clot and restore blood flow. It targets patients with sudden strokes caused by clots in medium-sized vessels.

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 data supports the effectiveness of the treatment Endovascular Thrombectomy (EVT) for stroke?

Research shows that Endovascular Thrombectomy (EVT) can improve outcomes for stroke patients by reducing disability 90 days after a stroke caused by a blockage in a large blood vessel. It is also suggested that fewer attempts to remove the clot during the procedure may lead to better recovery. ^{1 2 3 4 5}

Is endovascular thrombectomy (EVT) generally safe for humans?

Endovascular thrombectomy (EVT) is an invasive treatment for stroke that can lead to various medical complications and adverse events, but it is considered effective for acute ischemic stroke. Safety data is still being evaluated for different conditions and patient groups. ^{6 7 8 9 10}

How is the treatment Endovascular Thrombectomy (EVT) for stroke different from other treatments?

Endovascular Thrombectomy (EVT) is unique because it involves physically removing a blood clot from a blocked blood vessel in the brain, which is different from other treatments that may use medication to dissolve clots. This procedure is particularly effective for patients with large vessel occlusion (LVO) strokes and is performed using specialized tools inserted through blood vessels. ^{9 11 12 13 14}

Research Team

Mayank Goyal, MD

Principal Investigator

University of Calgary and Foothills Medical Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of endovascular thrombectomy in acute stroke patients with large ischemic core. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Among Patients With Acute Ischemic Stroke and Large Vessel Occlusion in the ESCAPE Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Higher number of stent-retriever thrombectomy passes significantly increases risk of mass effect, poor functional outcome, and mortality. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Endovascular Thrombectomy as a Means to Improve Survival in Acute Ischemic Stroke: A Meta-analysis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Redefining 'success': a systematic review and meta-analysis comparing outcomes between incomplete and complete revascularization. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Distal arterial occlusions in patients with mild strokes - is endovascular therapy superior to thrombolysis alone? [2020]

7. Denmark pubmed.ncbi.nlm.nih.gov

Medical complications and outcome after endovascular therapy for acute ischemic stroke. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Trial of Endovascular Thrombectomy for Large Ischemic Strokes. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Current advances in endovascular treatment. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Endovascular Thrombectomy vs Medical Management Alone in Patients With Large Ischemic Cores: A Secondary Analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Multicenter investigation of technical and clinical outcomes after thrombectomy for Proximal Medium Vessel Occlusion (pMeVO) by frontline technique. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Delayed Thrombectomy Center Arrival is Associated with Decreased Treatment Probability. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The efficacy and safety of general anesthesia vs. conscious sedation for endovascular treatment in patients with acute ischemic stroke: a systematic review and meta-analysis. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional vessel wall MRI to characterize thrombus prior to endovascular thrombectomy for large vessel occlusion stroke. [2022]