Actively Recruiting
Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
Led by Raul Nogueira · Updated on 2026-02-23
584
Participants Needed
4
Research Sites
186 weeks
Total Duration
On this page
Sponsors
R
Raul Nogueira
Lead Sponsor
S
Stryker Neurovascular
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well
CONDITIONS
Official Title
Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit
- Acute ischemic stroke with ineligibility for or failure of intravenous thrombolytic treatment due to absence of a proximal arterial occlusion
- Evidence of a primary distal medium vessel occlusion in specified cerebral artery segments with vessel diameters between 1.5mm and 2.5mm
- No significant disability before stroke (modified Rankin Scale score 2 or less)
- Disabling stroke with NIH Stroke Scale score greater than 5, or score 3-5 with disabling deficits
- Presence of a target mismatch on imaging with ischemic core less than 50cc, mismatch volume over 10cc, and mismatch ratio above 1.4
- Ability to receive treatment within 12 hours of symptom onset
- Informed consent provided by patient or acceptable surrogate
You will not qualify if you...
- Any signs of bleeding in the brain on baseline CT or MRI
- Rapidly improving symptoms likely to result in no disabling deficits and NIH Stroke Scale score less than 5 at randomization
- Significant ischemic changes outside the occluded area that might reduce treatment benefit
- Contraindications to MRI or CT with contrast agents
- Infarct core larger than one-third of the affected territory or greater than 50 mL
- Terminal illness with expected survival less than 1 year
- Recent history or presence of brain hemorrhage, aneurysm, arteriovenous malformation, or brain tumor other than meningioma
- Imaging findings suggesting futile recanalization
- Pre-existing severe disability (modified Rankin Scale score 3 or higher)
- Unable to start endovascular treatment within 12 hours of last seen well
- Seizures at stroke onset preventing accurate baseline assessment
- Extremely low or high baseline blood glucose levels
- Known bleeding disorders or low platelet count
- Known severe kidney failure
- Suspected septic embolus or bacterial infection of the heart valves
- Any condition posing significant risk for endovascular procedure
- History of drug or alcohol dependence interfering with study adherence
- Occlusions in multiple vascular territories
- Participation in other investigational drug or device studies impacting this trial
- Known pregnancy
- Prisoner or incarceration status
- Known acute symptomatic COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Grady Health System
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
2
UI Health Care Medical Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
ProMedica
Toledo, Ohio, United States, 43606
Actively Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
M
Mohamed Doheim, MD
CONTACT
E
Emma Gyurisin, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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