ClinConnect ClinConnect Logo
Search / Trial NCT07115940

Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well

Launched by AMROU SARRAJ · Aug 4, 2025

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Endovascular Thrombectomy Mechanical Thrombectomy

ClinConnect Summary

This clinical trial is studying whether adding a procedure called endovascular thrombectomy—a way to remove blood clots from large blood vessels in the brain—can help people who have had a type of stroke called an acute ischemic stroke, but who come to the hospital more than 24 hours after their symptoms started. The main goal is to see if this treatment, combined with usual medical care, helps patients recover better and regain more independence three months after their stroke.

Adults between 18 and 85 years old who have had this type of stroke caused by a large clot in certain brain arteries, and who still meet specific brain scan criteria, might be eligible. To join, patients need to have moderate to severe stroke symptoms, must have been last well between 24 and 72 hours ago, and need to be able to safely undergo the clot-removal procedure. If accepted, participants will receive either the usual medical treatment alone or medical treatment plus thrombectomy, and will be followed for about three months to see how well they recover. This trial is not yet recruiting, but it could offer important information about treating stroke patients who arrive later than usual after symptom onset.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • General Inclusion Criteria:
  • Adults (18-85\* years) with the final diagnosis of an acute ischemic stroke$
  • NIHSS ≥ 6
  • Time from last-known-well to randomization \>24 - 72 hours
  • Pre-stroke modified Rankin Scale score of 0-1
  • Eligible for thrombectomy and medical management
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least 3 months \*Inclusive of both 18 and 85 years of age (i.e. up to 86th birthdate). $Subacute presentation - In-hospital stroke admissions with fluctuating clinical symptoms for patients who presented to EVT centers within 24 hours of when they were last known well will not be eligible for the trial.
  • General Exclusion Criteria
  • • Current participation in another investigational interventional drug or device study.
  • Imaging Inclusion Criteria
  • Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions), as determined by MR Angiography (MRA) or CT Angiography (CTA)
  • CT ASPECTS 3-10
  • CT Perfusion ischemic core (rCBF \<30%)# volume ≤150 ml OR MR Diffusion ischemic core (ADC \<620x10-6 mm2/s)# volume ≤150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.
  • Imaging Exclusion Criteria
  • Evidence of intracranial tumor (except small meningioma \<3cm without signs of edema or inflammation), acute intracranial hemorrhage, or arteriovenous malformation
  • Significant mass effect with midline shift (\>1mm)
  • Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
  • Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
  • Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
  • Any signs of established infarct, demarcating hypodensity and area of cerebral edema on non-contrast CT
  • CT ASPECTS 0-2
  • CT Perfusion ischemic core (rCBF \<30%)# volume \>150 ml OR MR Diffusion ischemic core (ADC \<620x10-6 mm2/s)# volume \>150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.

About Amrou Sarraj

Amrou Sarraj is a clinical trial sponsor specializing in advancing medical research through the design and oversight of innovative clinical studies. With a focus on developing evidence-based therapies, Sarraj is committed to improving patient outcomes by facilitating rigorous, ethically conducted trials that adhere to regulatory standards and promote scientific integrity.

Locations

Patients applied

0 patients applied

Trial Officials

Amrou Sarraj, MD

Principal Investigator

University Hospitals

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported