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Endovascular Therapy for Late Window Stroke Patients

This study, called DONE SYMPLE, is testing if a procedure called Endovascular Therapy (Mechanical Thrombectomy) can help more stroke patients recover, even when performed up to 72 hours after their stroke symptoms started. Endovascular Therapy removes blood clots from brain arteries. Currently, this treatment is usually guided by advanced brain scans, but this study is exploring if a standard CT scan with special software can be used instead. This could make the treatment available to more people, especially in places without advanced imaging. You might be able to join if you are 18-80 years old, had a stroke 6-72 hours ago, and have a pre-stroke Modified Rankin Scale (mRS) score of 0-1 (or 0 if over 70). The main goal is to see how much your global disability improves 90 days after treatment. The study status is currently unclear.

Study design
This is a Phase III, randomized study involving 500 participants. It is open-label, meaning both you and your doctors will know which treatment you receive, but the assessment of your recovery will be done by people who don't know.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your global disability will be measured 90 days (plus or minus 14 days) after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07001852

EnDOvascular Therapy for Late WiNdow IschEmic Stroke Patients Selected bY AutoMatic Plain ComputErized Tomography

Recruiting
NAAges 18–80InterventionalTreatment
Santiago Ortega Gutierrez
~500 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:Endovascular Therapy (Mechanical Thrombectomy)Standard Medical Management

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Global Disability at 90 Days
Measured over 90 days (±14 days)

Conditions

Stroke Acute

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Acute Ischemic Stroke

NCT07001852

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa

    Iowa City, Iowastudy coordinator listed

    Not yet recruiting

  • Erebouni Medical Center

    Yerevan, Armeniano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tudor Jovin, MD · PRINCIPAL_INVESTIGATOR · Cooper University Health Care
  • Marc Ribo, MD · PRINCIPAL_INVESTIGATOR · Hospital Vall d"Hebron Barcelona

Who to contact

Santiago Ortega, MD
[email protected]
319-3845628
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patients in the 6-24-hour after Last Known Well (LKW) may be enrolled only in centers where thrombectomy is not offered as standard of care due to the absence of advanced imaging capabilities.
In cases of discrepancy between the automated tool LVO detection and volume, and ASPECT Score or CTA judgment or Computed Tomography Angiography CTA findings, ASPECTS and CTA will take precedence.
If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed, and his/her consent is requested for the possible continuation of this research.

Exclusion

Midline shift or herniation.
Evidence of intracranial hemorrhage.
Mass effect with effacement of the ventricles. 5. Bilateral strokes. 6. Clot retrieval previously attempted \<6 hours. 7. Treated with thrombolytics \>4.5 hours after last seen well. 8. Intracranial tumors. 9. Life expectancy less than 90 days prior to stroke onset. 10. Participation in another randomized clinical trial that could confound the evaluation of the study. 11. Presumed septic embolus, or suspicion of bacterial endocarditis. 12. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept). 13. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed.

What this trial measures

  • Global Disability at 90 Days90 days (±14 days)

    Global disability will be measured using the disability-weighted modified Rankin Scale (dw-mRS) at 90 days (±14 days) post-stroke. The dw-mRS is a validated tool that captures the severity of post-stroke disability across seven levels, ranging from no symptoms (0) to death (6). This outcome evaluates whether endovascular therapy (EVT) plus medical management results in superior functional outcomes compared to medical management alone in patients with anterior circulation large vessel occlusion (LVO) strokes treated between 6-72 hours after stroke onset and selected exclusively by automated non-contrast CT imaging.