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Procedure

Thrombectomy for Stroke (DUSK Trial)

N/A

Waitlist Available

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).***

Must not have

Known renal failure as defined as serum creatinine levels > 3.0 mg/dL

Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours (-2 hours/+12 hours)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is impaired with creatinine levels above 3.0 mg/dL.

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I have had a recent brain bleed, AV malformation, aneurysm, or brain tumor.

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I cannot undergo MRI or CT scans with contrast due to health reasons.

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I might have an infection in my heart or blood clots caused by an infection.

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I currently have symptoms of COVID-19.

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I had significant disability before my current illness.

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I have blockages in multiple blood vessel areas.

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I couldn't start treatment within 12 hours of feeling well for the last time.

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I have a bleeding disorder or my platelet count is below 100,000.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours (-2 hours /+12 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours (-2 hours /+12 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours (-2 hours /+12 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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