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

Launched by SANTIAGO ORTEGA GUTIERREZ · May 23, 2025

Keywords

ClinConnect Summary

The DONE SYMPLE Trial is a global study designed to find out if a treatment called endovascular therapy can help more stroke patients recover better when it's used within 72 hours of their symptoms starting. This therapy works by removing blood clots from blocked arteries in the brain. Currently, this treatment is known to help patients if they are treated within 6 hours, but the challenge is that many hospitals don’t have the advanced imaging technology needed to determine who would benefit. This trial will explore whether a simpler type of brain scan, called a non-contrast CT, can be used instead to identify patients who still have healthy brain tissue that can be saved.

To participate in the trial, patients need to be between 18 and 80 years old and show signs of a certain type of stroke within 6 to 72 hours after their last known well time. They will undergo a basic CT scan, and if it shows the right conditions, they will be randomly assigned to either receive standard medical treatment or the endovascular therapy. Throughout the study, their recovery will be closely monitored for 90 days. This trial could potentially change how stroke care is delivered worldwide, especially in areas where advanced imaging is not available, making it easier for more patients to access life-saving treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 18 to 80 years of age:
• • 1. Pre-stroke score (mRS) of 0-1 in participants aged 18 to 70 years.
• • 2. Pre-stroke Modified Rankin Scale (mRS) score of 0 in participants older than 70 years.
• • 2. Presenting with signs and symptoms consistent with an acute ischemic stroke within 24-72 hours from last known well. \*
• • 3. Baseline NIHSS ≥8.
• • 4. NCCT imaging indicating the existence of an anterior circulation LVO by an automated software, or CTA (when available).
• • 5. Core volume ≤ 70 cc determined by a deep learning algorithm in automated software and/or ASPECTS scoring ≥ 6. \*\*
• • 6. Arterial puncture within 72 hours (after the first symptoms or LKW).
• • 7. Arterial puncture within 90 minutes from initial CT.
• • 8. Ability to randomize within 72 hours after stroke onset (last seen well).
• • 9. Ability to obtain signed informed consent or subject's Legally Authorized representative (LAR) has signed Consent form \*\*\*
• • 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 Criteria:
• • 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test.
• • 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
• • 3. Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication.
• 4. CT evidence of the following conditions:
• • 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.