💬In plain words
What the trial is, and whether it could suit you
The DONE SYMPLE Investigator-initiated phase III prospective, randomized, open-label, blinded endpoint-controlled clinical trial.
This clinical trial is a global clinical study testing whether a procedure called endovascular therapy, which removes blood clots from blocked brain arteries, can safely benefit more stroke patients when used up to 72 hours after symptoms begin. Endovacular Therapy is already proven to improve recovery in patients treated within 6 hours, but only when advanced imaging like Computed Tomography (CT) perfusion or Magnetic Resonance Imaging (MRI) is available to guide treatment. Unfortunately, many hospitals, specially in underserved areas, do not have access to this type of imaging.
This trial will investigate whether a basic brain scan called non-contrast CT, which is widely available in hospitals around the world, can be used instead. Special software will au
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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