Thrombectomy for Stroke

(DUSK Trial)

Overseen By Emma Gyurisin, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Raul Nogueira

Disqualifiers: Intracranial hemorrhage, Terminal illness, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 hours from time last seen well

584 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if endovascular thrombectomy (a minimally invasive surgery to remove a blood clot) is more effective than standard medical treatment for a specific type of stroke. The trial focuses on strokes caused by blockages in smaller blood vessels in the brain, which can lead to significant issues like speech and movement difficulties. Participants must have experienced a stroke that cannot be treated with typical clot-busting drugs and must be treatable within 12 hours of symptom onset. As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could enhance future stroke treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that endovascular thrombectomy is safe for stroke patients?

Research shows that endovascular thrombectomy, a procedure to remove clots from blood vessels, is generally safe for patients with strokes caused by blockages in smaller blood vessels. Studies have found that this treatment often leads to better recovery for patients. However, the procedure carries a higher risk of brain bleeding (hemorrhage). Specifically, the chance of experiencing a noticeable brain bleed is more than twice as high compared to those not receiving this treatment. Despite this risk, many patients recover well after the procedure, which can effectively restore blood flow. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for stroke?

Researchers are excited about endovascular thrombectomy because it offers a new approach to treating strokes caused by distal medium vessel occlusions. Unlike traditional treatments that rely on medication to dissolve clots, this procedure involves physically removing the clot using a special catheter inserted into the blood vessel. This direct method not only has the potential to quickly restore blood flow to the brain, but it can also be more effective in cases where medication alone might not work. As a result, endovascular thrombectomy could significantly improve recovery outcomes for stroke patients.

What evidence suggests that endovascular thrombectomy might be an effective treatment for ischemic stroke?

This trial will compare endovascular thrombectomy with standard medical care for patients with distal medium vessel occlusion. Studies have shown that endovascular thrombectomy, a procedure to remove blood clots from blood vessels, does not significantly aid recovery from these strokes compared to standard medical care. Although this treatment can lead to a high survival rate after three months, it does not improve patient function or reduce death rates. Some research suggests the procedure might increase the risk of complications, such as bleeding in the brain. Observational studies have found its effectiveness and safety to be similar to its use for larger blood vessel blockages. Overall, current evidence does not strongly support endovascular thrombectomy as a superior option for this type of stroke. ^{4 6 7 8 9}

Who Is on the Research Team?

Raul G Nogueira, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a blockage in a specific small blood vessel in my brain that can be treated with a procedure.

Informed consent obtained from patient or acceptable patient surrogate

You had a stroke that left you with significant difficulties in speaking, seeing, or moving your body.

Exclusion Criteria

You have a large area of damage in your brain from a stroke.

Prisoner or incarceration

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either endovascular thrombectomy or standard medical management for distal medium vessel occlusion ischemic stroke

12 hours from time last seen well

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 24 hours and 90 days

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Thrombectomy

Trial Overview 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.

How Is the Trial Designed?

Group I: Endovascular Thrombectomy Experimental Treatment 1 Intervention

Endovascular thrombectomy in patients who suffer a distal medium vessel occlusion.

Group II: Standard of Care Treatment Active Control 1 Intervention

Standard medical management in patients who suffer a distal medium vessel occlusion

Who Is Running the Clinical Trial?

Raul Nogueira

Lead Sponsor

Trials

1

Recruited

560+

Stryker Neurovascular

Industry Sponsor

Trials

36

Recruited

12,800+

Brainstorme Imaging Core Lab Inc

Collaborator

Trials

1

Recruited

560+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

Citations

1. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.125.042299?doi=10.1161/JAHA.125.042299

Thrombectomy for Distal Medium Vessel Occlusion: A Meta ... Thrombectomy did not improve functional outcomes or reduce mortality compared with medical management but was associated with increased risks of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11703498/

Endovascular therapy versus best medical care for acute ... For patients with AIS and DMVO occlusion, EVT fails to improve functional prognosis while increasing sICH incidence.

3. link.springer.com link.springer.com/article/10.1007/s10143-025-03835-0

Endovascular thrombectomy for distal medium vessel ... Rate of 90-day overall survival (mRS 0–5) was reported for 1230 patients in three trials [7, 8, 14]. Overall survival at three months was 86.6% ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000214015

Endovascular Treatment in Acute Ischemic Stroke Due to ... The present meta-analysis demonstrates that EVT does not significantly improve excellent or good functional outcomes at 3 months compared with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1052305725000990

Safety and efficacy of mechanical thrombectomy in distal ... Observational studies have demonstrated comparable efficacy and safety of mechanical thrombectomy (MT) in DMVOs compared to LVOs.

6. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.125.042299

Thrombectomy for Distal Medium Vessel Occlusion: A Meta ... However, thrombectomy was associated with a higher risk of hemorrhage, with an odds ratio of 2.18 (95% CI, 1.24–3.83) for symptomatic ICH and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035353/

Endovascular thrombectomy for distal vessel occlusion stroke This single-center real-world experience demonstrates that EVT in patients with DVO stroke is safe and feasible and may lead to improved clinical outcome.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1052305724005779

Endovascular thrombectomy for distal medium vessel ... Successful revascularization was achieved in 58% of the patients with a single pass using the microcatheter aspiration thrombectomy (MAT) technique and 68% had ...

9. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.045228

The DUSK Study | Stroke This multicenter study failed to demonstrate any significant outcome differences among patients with isolated distal medium vessel occlusions treated with EVT ...