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Procedure
Thrombectomy for Stroke (DUSK Trial)
N/A
Recruiting
Led By Raul G Nogueira, MD
Research Sponsored by Raul Nogueira
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of a primary distal medium vascular occlusion defined as occlusion of the non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy. Non dominant M2 segment vessel diameter should not exceed 2.5mm.
Acute ischemic stroke where patient is ineligible for or has failed* IV thrombolytic treatment and is ineligible for endovascular treatment under best guideline-based care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and co-dominant or dominant M2** segments, and vertebrobasilar arteries).***
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours (-2 hours/+12 hours)
Awards & highlights
DUSK Trial Summary
This trial will look at whether a new stroke treatment is better than existing care for those who have had a stroke in the last 12 hrs.
Who is the study for?
This trial is for adults over 18 with acute ischemic stroke from a blockage in medium-sized vessels, who can't have or didn't improve with standard clot-dissolving treatment. They must be treatable within 12 hours of symptoms starting and not have severe pre-stroke disabilities. Excluded are those improving rapidly, with other significant brain damage, terminal illnesses, certain blood conditions, drug/alcohol dependency affecting study adherence, known pregnancy or incarceration.Check my eligibility
What is being tested?
The trial tests if physically removing the clot (endovascular thrombectomy) is better than just giving medicine for strokes caused by clots in medium-sized brain arteries. Participants will either receive this new procedure or stick to standard medical care without it.See study design
What are the potential side effects?
Potential side effects of endovascular thrombectomy include bleeding in the brain, infection at the puncture site, allergic reaction to contrast dye used during imaging before the procedure and possible damage to blood vessels where the clot is removed.
DUSK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blockage in a specific small blood vessel in my brain that can be treated with a procedure.
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I had a stroke and can't have standard clot-dissolving treatments or procedures due to specific artery conditions.
Select...
I was mostly independent before my stroke.
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I had a stroke with specific brain scan results and can be treated within 12 hours of symptom onset.
DUSK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours (-2hours /+12 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours (-2hours /+12 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Shift in distribution of all levels of the 90-day modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment
Secondary outcome measures
All cause mortality
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Clinical improvement at 24 hours calculated as the difference between 24-hour and baseline NIHSS score
+25 moreDUSK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endovascular ThrombectomyExperimental Treatment1 Intervention
Endovascular thrombectomy in patients who suffer a distal medium vessel occlusion.
Group II: Standard of Care TreatmentActive Control1 Intervention
Standard medical management in patients who suffer a distal medium vessel occlusion
Find a Location
Who is running the clinical trial?
Raul NogueiraLead Sponsor
Stryker NeurovascularIndustry Sponsor
35 Previous Clinical Trials
12,175 Total Patients Enrolled
13 Trials studying Ischemic Stroke
6,849 Patients Enrolled for Ischemic Stroke
Brainstorme Imaging Core Lab IncUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a large area of damage in your brain from a stroke.My kidney function is impaired with creatinine levels above 3.0 mg/dL.I have a blockage in a specific small blood vessel in my brain that can be treated with a procedure.I have had a recent brain bleed, AV malformation, aneurysm, or brain tumor.I cannot undergo MRI or CT scans with contrast due to health reasons.Your blood sugar level is too low (less than 50 mg/dL) or too high (more than 400 mg/dL).I had seizures when my stroke started, making it hard to assess my initial stroke severity.I might have an infection in my heart or blood clots caused by an infection.I have a health issue that makes it unsafe for me to undergo procedures involving blood vessels.I currently have symptoms of COVID-19.You had a stroke that left you with significant difficulties in speaking, seeing, or moving your body.I had a stroke and can't have standard clot-dissolving treatments or procedures due to specific artery conditions.I had significant disability before my current illness.I have blockages in multiple blood vessel areas.You have significant blockages in your blood vessels that could make the treatment less effective, according to the doctor.You have an illness that is so serious that doctors think you may not live for more than a year.I was mostly independent before my stroke.The doctor thinks that any attempts to reopen blocked blood vessels won't be helpful based on your scans.My symptoms are quickly getting better, and my doctor believes I will have no lasting disabilities.I had a stroke with specific brain scan results and can be treated within 12 hours of symptom onset.I couldn't start treatment within 12 hours of feeling well for the last time.I have a bleeding disorder or my platelet count is below 100,000.I am 18 years old or older.You have evidence of bleeding in your brain on a baseline CT or MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Treatment
- Group 2: Endovascular Thrombectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this research trial?
"According to the information posted on clinicaltrials.gov, this medical trial has concluded its patient recruitment phase and therefore is not actively searching for participants. The original post of the study was September 1st 2023 while its most recent updatge took place August 1st 2023. Despite this particular study's completion, 1371 other trials remain ongoing and are seeking new patients."
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