Endovascular Stenting for Acute Ischemic Stroke

Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

Recruiting Phase 3 Interventional Study
Brain Stroke Stenting Treatment Acute Ischemic Stroke
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
342 (estimated)
Sponsor
ProMedica Health System · Other
Who this trial is looking for

This trial is looking for patients aged 18 to 80 who have had a recent stroke and still have a blockage in a brain artery after treatment. Taking part involves undergoing a procedure to clear the blockage while also receiving stenting treatment if needed.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 80 years old
  • I have had symptoms of a stroke
  • I have imaging showing a blockage in the Internal Carotid Artery or Middle Cerebral Artery
  • I have 70-99% blockage remaining after a clot retrieval attempt
  • I have a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher
  • I can start within 24 hours of my stroke
  • I can provide signed consent
  • I have an ASPECTS score of 6 or higher

You may not be able to join if

  • I am pregnant or have a positive pregnancy test
  • I have a severe allergy to contrast media
  • I have a midline shift, herniation, or intracranial hemorrhage
  • I have had a stroke on both sides of my brain
  • I cannot take antiplatelet medications or contrast agents
  • I have a recent diagnosis of atrial fibrillation
  • I have been diagnosed with certain tumors that require surgery
  • My platelet count is below 80,000 per microliter

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 to 80 years of age 2. Presenting with symptoms consistent with AIS 3. Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery follow…
Contacts

Sami Al Kasab, MD

4192913498

alkasab@musc.edu

CONTACT

Mouhammad Jumaa, MD

Mouhammad.JumaaMD@ProMedica.org

CONTACT