NCT07001852: DONE SYMPLE

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

Recruiting now NA Last updated 16 October 2025

What this trial tests

NA trial testing Endovascular Therapy (Mechanical Thrombectomy) in Stroke Acute in 500 participants. Currently enrolling.

Timeline

14 October 2025

Primary endpoint
1 July 2029

1 July 2029

Quick facts

Lead sponsor	Santiago Ortega Gutierrez
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	500
Start date	14 October 2025
Primary completion	1 July 2029
Estimated completion	1 July 2029
Sites	2 locations across United States, Armenia

Drugs / interventions tested

• Endovascular Therapy (Mechanical Thrombectomy)
• Standard Medical Management — full drug profile →

Conditions studied

• Stroke Acute — all drugs for Stroke Acute →

Sponsor

Santiago Ortega Gutierrez

Who can join

Adults 18 to 80, any sex, with Stroke Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 automatically analyze the CT scan to help doctors decide if a patient has enough brain tissue left to save with Endovascular Therapy. If this simpler approach works, it could expand access to lifesaving stroke care for more people globally.

The study will enroll 500 adult stroke patients, ages 18 to 80, with a large vessel blockage in the brain's anterior circulation, moderate to severe stroke symptoms, and who are between 6 and 72 hours from when they were last known to be well. All participants will undergo CT imaging analyzed by the automated software. If the scan shows a small core of already damaged brain tissue and a larger area of threatened but still viable brain, the patient will qualify.

Participants will be randomly assigned to receive either standard medical therapy alone or medical therapy plus Endovasculat Therapy which involves inserting a catheter through a blood vessel to reach the brain and using a device to remove the clot. This procedure is performed by trained stroke or neurointerventional specialists. The study is "open-label," meaning patients and doctors know which treatment is given, but the assessment of patient recovery will be done by independent reviewers who do not know the group assignments.

The primary goal is to determine if patients who receive Endovascular Therapy have better recovery at 90 days, measured by a scale called the modified Rankin Scale, which assesses how much disability a patient has after a stroke. The trial will also look at safety (especially brain bleeding after treatment), size and growth of brain injury on follow-up scans, recovery of strength and language, and overall quality of life and survival. Imaging will be reviewed centrally by a specialized team, and results will be analyzed to see how well Endovascular Therapy performs using this new patient selection method.

The DONE SYMPLE Trial is sponsored by Foundacio Ictus in Barcelona Spain and the University of Iowa is the Central Coordinating Center for the Study. It will take place at up to 20 hospitals worldwide. All patients will be followed closely with exams and imaging at specific time points up to 90 days after treatment.

If successful, this trial could change stroke care around the world by proving that Endovascular Therapy can be used safely and effectively even without advanced imaging, using tools available in most hospitals. This could help more stroke patients, especially in rural or resource-limited areas, access treatments that may improve their chances of recovery and reduce long-term disability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Endovascular Therapy for Acute Ischemic Stroke Beyond 24 Hours After Onset: A Nationwide Registry-Based Analysis.
   Inui R, Tanaka K, Toyoda K, Yoshimura S, et al · · 2026 · PMID 42088328 · DOI 10.1161/svin.125.002024