Endovascular Therapy for Stroke

(DONE SYMPLE Trial)

Recruiting at 1 trial location

Overseen By Santiago Ortega, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Santiago Ortega Gutierrez

Must not be taking: Thrombolytics, Anti-cholinesterase

Disqualifiers: Pregnancy, Refractory hypertension, Intracranial tumors, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate (6-72 hours post-stroke)

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores endovascular therapy to improve stroke recovery when administered up to 72 hours after symptom onset. It examines whether a basic brain scan can safely guide treatment instead of advanced imaging like CT perfusion or MRI. The goal is to expand access to lifesaving stroke care, especially in hospitals without advanced equipment. Suitable candidates include those who have experienced a moderate to severe stroke with a large artery blockage in the brain and are between 6 and 72 hours from when they were last known to be well. Participants will receive either standard medical care or additional endovascular therapy, which involves a procedure to remove the clot. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could enhance stroke care accessibility for many patients.

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 team or your doctor to get specific guidance based on your situation.

What prior data suggests that endovascular therapy is safe for stroke patients?

Research has shown that endovascular therapy, a treatment for strokes, is generally safe and effective. Previous studies found that it significantly aids stroke recovery, reducing disability after 90 days. Although risks exist, such as bleeding in the brain, these occur in a small number of cases. One study found a 20% chance of serious issues like bleeding. However, the benefits, such as improved long-term recovery, often outweigh these risks. This procedure is already a trusted treatment when used with advanced imaging, and this trial examines its effectiveness with more commonly available tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endovascular therapy for stroke because it offers a unique approach compared to standard treatments like medication for dissolving clots. Unlike traditional methods, endovascular therapy involves mechanically removing the clot using a device inserted through a blood vessel, which can be initiated within 6 to 72 hours after a stroke. This method allows for direct intervention at the site of the blockage, potentially leading to quicker and more effective restoration of blood flow to the brain. By using automated CT software for patient selection, this therapy ensures that only those who are most likely to benefit receive it, enhancing its potential effectiveness.

What evidence suggests that Endovascular Therapy could be an effective treatment for stroke?

Studies have shown that endovascular therapy, a procedure to remove blood clots from blocked brain arteries, helps stroke patients recover better. In this trial, one group of participants will receive endovascular therapy combined with standard medical management. This treatment outperforms medication alone, particularly for those with major artery blockages. Research suggests that using this therapy even after 24 hours from the onset of stroke symptoms can lead to better outcomes, including reduced disability and lower death rates. If effective with simpler imaging techniques, this life-saving treatment could become accessible to more people worldwide. ^{1 3 6 7 8}

Who Is on the Research Team?

Tudor Jovin, MD

Principal Investigator

Cooper University Health Care

Marc Ribo, MD

Principal Investigator

Hospital Vall d"Hebron Barcelona

Are You a Good Fit for This Trial?

Adults aged 18-80 with a large vessel blockage in the brain, moderate to severe stroke symptoms, and within 6-72 hours from when they were last known well. They must have a CT scan showing potential for recovery using Endovascular Therapy. Not suitable for those outside this age range or time window, with different types of strokes or conditions that would interfere with treatment.

Inclusion Criteria

I showed stroke symptoms 1-3 days after feeling normal.

Ability to obtain signed informed consent or subject's Legally Authorized representative (LAR) has signed Consent form

Core volume ≤ 70 cc determined by a deep learning algorithm in automated software and/or ASPECTS scoring ≥ 6

Exclusion Criteria

CT evidence of specific conditions

Participation in another randomized clinical trial

Known severe allergy to contrast media uncontrolled by medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either standard medical therapy alone or medical therapy plus Endovascular Therapy within 6 to 72 hours of stroke onset

Immediate (6-72 hours post-stroke)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at specific time points up to 90 days

90 days

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants' global disability and quality of life are assessed at 90 days post-treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Therapy

Trial Overview The trial is testing if Endovascular Therapy (mechanical removal of blood clots) guided by basic CT scans can improve recovery in late-window ischemic stroke patients compared to standard medical management alone. It's an open-label study where participants know their treatment; outcomes are assessed blindly at 90 days.

How Is the Trial Designed?

Group I: Endovascular Therapy + Standard Medical Management Active Control 2 Interventions

Participants in this arm will receive standard medical management for acute ischemic stroke plus endovascular therapy (mechanical thrombectomy). Treatment is initiated within 6 to 72 hours of stroke onset and is guided by automated non-contrast CT selection software.

Group II: Standard Medical Management Alone Active Control 1 Intervention

Participants in this arm will receive standard medical management for acute ischemic stroke without undergoing endovascular therapy. Treatment decisions are made according to institutional protocols and exclude mechanical thrombectomy.

Who Is Running the Clinical Trial?

Santiago Ortega Gutierrez

Lead Sponsor

Trials

1

Recruited

2,000+

Fundació Ictus

Collaborator

Trials

1

Recruited

2,500+

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/PMC10370678/

Clinical Outcomes of Mechanical Thrombectomy for Acute ... Clinical outcomes of transferred patients for endovascular thrombectomy may be equivalent to those of directly transported patients.

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846724004979

Endovascular thrombectomy after 24 hours for patients with ... The SELECT Late Study demonstrated that patients who were treated with EVT after 24 hours of the LKW achieved more functional independence and reduced mortality ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2467553

Endovascular Thrombectomy for Acute Ischemic Stroke Endovascular therapy with mechanical thrombectomy vs standard medical care with tPA was associated with improved functional outcomes and higher rates of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671138/

Outcomes and Complications Associated with Mechanical ... It was shown that mechanical thrombectomy significantly reduced disability at 90 days compared to control patients, especially in patients over ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1052305724006517

Endovascular thrombectomy for acute ischemic stroke with ... Pooled meta-analysis of secondary outcomes analysis revealed a 3-month mortality rate of 0.20 (95 % CI: 0.15-0.26), while the rate of symptomatic intracerebral ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804474

Endovascular Therapy for Stroke Presenting Beyond 24 ... These findings suggest that EVT may be safe and associated with favorable outcome distributions for patients with very late-window acute ischemic stroke.