Endovascular Treatment for Stroke

Overseen By Song Srisilpa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Pregnancy, Incarceration, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Within 72 hours of stroke onset

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores endovascular therapy (EVT), which uses small tools to remove blockages in major brain arteries during a stroke. The researchers aim to determine if EVT can reduce complications, such as neurological issues, that may occur even after a successful procedure. This study targets individuals who have experienced a stroke in the main brain arteries and have already undergone EVT. Participants should have had a stroke in the anterior circulation, which includes specific parts of the brain's main arteries. Those who recently experienced this type of stroke and underwent EVT may be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to understanding EVT's effectiveness and potentially improve future stroke care.

Do I need to stop my current medications for the trial?

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 this endovascular treatment is safe for stroke patients?

Studies have shown that endovascular treatment (EVT) effectively aids recovery for people who have had a stroke due to blockages in large blood vessels. Research indicates that EVT can lead to better recovery compared to standard medical care alone.

However, some risks require consideration. Evidence suggests that after EVT, some patients may experience early neurological deterioration (END), with symptoms worsening shortly after the procedure. This occurs in about 14.1% to 35.2% of cases. Additionally, a smaller group, around 5.9% to 10.5%, may experience symptomatic intracranial hemorrhage (sICH), a serious complication involving bleeding in the brain.

These risks underscore the need to weigh the benefits of EVT against potential side effects. Overall, EVT has shown promise in aiding stroke recovery, but awareness of possible outcomes is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stroke, like clot-busting drugs, aim to dissolve blood clots and restore blood flow. However, the endovascular treatment being studied is unique because it physically removes the clot using a catheter, which is a tube inserted into the blood vessel. This approach can be quicker and more direct, especially for large clots that don't respond well to medication. Researchers are excited about this method because it has the potential to improve outcomes for patients with severe strokes, particularly in cases involving tandem occlusions, where multiple blockages occur.

What is the effectiveness track record for endovascular treatment for stroke?

Studies have shown that endovascular treatment (EVT) effectively aids recovery from strokes caused by large blood vessel blockages. Research indicates that EVT significantly reduces disability 90 days post-stroke compared to medication alone. EVT has proven effective for strokes affecting major blood vessels in the brain's front part. However, while the treatment is beneficial, some patients may still experience issues such as early symptom worsening or brain bleeding. Despite these risks, EVT is generally considered safe and offers better recovery prospects than traditional medical treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Aarti Sarwal

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for patients who have had a stroke due to a blockage in a large artery and are undergoing endovascular therapy. It's not clear what specific conditions exclude someone from participating, as the exclusion criteria were not provided.

Inclusion Criteria

I am 18 years old or older.

I had a stroke in the front part of my brain and received a clot removal procedure.

Exclusion Criteria

Incarcerated patients

Difficulty in detecting the acoustic window by TCD

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular therapy (EVT) is performed on patients with acute ischemic stroke caused by large vessel occlusions

Within 72 hours of stroke onset

In-hospital procedure

Follow-up

Participants are monitored for neurological outcomes and complications such as early neurological deterioration and intracranial hemorrhage

3 months

Regular follow-up visits

Long-term Follow-up

Participants' discharge disposition and long-term outcomes are assessed

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Treatment

Trial Overview The study is looking at how Doppler ultrasound (TCD) measurements after stroke treatment can predict outcomes. Patients' clinical data will be collected, and they'll receive follow-up calls to assess their recovery over time.

How Is the Trial Designed?

Group I: Anterior circulation stroke that underwent EVT including tandem occlusions Experimental Treatment 5 Interventions

Subjects with anterior circulation stroke including ACA, MCA or ICA stroke that underwent EVT including tandem occlusions

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001581

Endovascular Therapy in Patients With Acute Ischemic ... Endovascular therapy is highly effective in improving functional outcomes in patients with acute ischemic stroke from large vessel occlusion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11270839/

Endovascular thrombectomy in patients with anterior ... Endovascular thrombectomy (EVT) has been proven effective in anterior circulation stroke due to large vessel occlusion (LVO).

3. 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 ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923000697

The Safety and Efficacy of Endovascular Treatment in ... This study aimed to investigate the safety and efficacy of endovascular treatment (EVT) in acute ischemic stroke (AIS) patients caused by large-vessel ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797595

Endovascular Therapy vs Medical Management for ... In conclusion, the findings of this multicenter cohort study suggest that EVT is safe and may be associated with higher rates of excellent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10965727/

Endovascular treatment of patients with stroke caused by ... Occlusion of the anterior cerebral artery (ACA) is uncommon but may lead to significant disability. The benefit of endovascular treatment (EVT) for ACA ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000214015

Endovascular Treatment in Acute Ischemic Stroke Due to ... The present meta-analysis demonstrates that EVT does not significantly improve excellent or good functional outcomes at 3 months compared with ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818220

Endovascular Therapy and Outcomes Among Patients With ... EVT was associated with higher proportion of favorable functional outcome at 90 days compared with standard medical treatment alone.