Endovascular clot-removal guided by automated standard CT for late-window ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DONE SYMPLE Trial is a phase III, multicenter, randomized, open-label trial with blinded endpoint assessment that will enroll 500 patients with anterior circulation large-vessel occlusion treated 6–72 hours after last known well. Participants are randomized 1:1 to standard medical therapy alone or endovascular thrombectomy plus standard therapy, with stratification by baseline NIH Stroke Scale, time from onset, core infarct volume, and enrolling site. Patient selection relies solely on automated analysis of non-contrast CT to detect vessel occlusion and estimate ischemic core (≤70 cc or ASPECTS ≥6), enabling enrollment at centers without perfusion or MRI capability. Endovascular procedures use approved thrombectomy devices and outcomes are adjudicated blinded to treatment allocation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Erebouni Medical Center
  Yerevan, Armenia Recruiting
• University of Iowa
  Iowa City, Iowa, United States Not yet recruiting

Study contacts

• Principal investigator: Tudor Jovin, MD — Cooper University Health Care
• Study coordinator: Santiago Ortega, MD
• Email: santy-ortega@uiowa.edu
• Phone: 319-3845628

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effectiveness of a new neurorehabilitation technology for stroke recovery

  This study is testing a new rehabilitation technology that uses robots and virtual reality to see if it can help stroke patients recover better than regular therapy.

  Recruiting Neurotechnika · Samara, Samara Oblast · NCT06753006

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

• Inter-Limb Transfer after Acute Stroke

  This study tests whether practicing motor skills with the affected arm helps improve movement in the other arm after an acute stroke.

  Recruiting at 2 sites University Hospital of Mont-Godinne · Yvoir, Namur and 1 other locations · NCT07822633

• Immersive Virtual Reality in Upper-Limb Rehabilitation After Stroke

  This trial tests whether adding immersive virtual reality to standard upper-limb rehabilitation helps stroke patients recover more function and quality of life.

  Recruiting Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Girona · NCT07609966

• Anakinra After Endovascular Therapy for Ischemic Stroke

  This trial tests whether giving two doses of Anakinra after successful endovascular treatment can reduce brain damage and improve outcomes in adults with acute ischemic stroke.

  Recruiting at 6 sites Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 5 other locations · NCT07423975

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.