Endovascular Therapy for Stroke
(DONE SYMPLE Trial)
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.12345
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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard medical therapy alone or medical therapy plus Endovascular Therapy within 6 to 72 hours of stroke onset
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at specific time points up to 90 days
Long-term Follow-up
Participants' global disability and quality of life are assessed at 90 days post-treatment
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?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Santiago Ortega Gutierrez
Lead Sponsor
Fundació Ictus
Collaborator
Citations
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 ...
Clinical Outcomes of Mechanical Thrombectomy for Acute ...
Clinical outcomes of transferred patients for endovascular thrombectomy may be equivalent to those of directly transported patients.
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.
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 ...
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 ...
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 ...
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 ...
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.
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