AzTrials
AzTrials

Ischemic StrokeDUSKNCT05983757

Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe

A study testing Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion and Standard medical management in people with Ischemic Stroke, run by Raul Nogueira at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion and Standard medical management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
584 participants
Where
4 sitesUnited States
Study dates
2 Apr 2024to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years (no upper age limit)
  • 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).*
  • IV thrombolytic treatment failure is defined by persistent disabling neurological deficits beyond 60 minutes of completion of thrombolytic infusion in the presence of imaging findings consistent with DMVO.
  • Dominant M2 segment is defined is a division supplying >50% of the MCA territory vs co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% of the MCA territory.
  • No procedures or tests required by the protocol will delay fastest possible delivery of thrombolytic therapy to potentially eligible subjects.
  • Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) 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. Regardless of vessel anatomic location, all vessel diameters should be within 1.5mm -2.5mm. (refer to the device labeling for recommended vessel diameters for each device model.)*
Show all 17Show fewer
  • No significant pre-stroke functional disability (mRS ≤2)
  • Evidence of a disabling stroke defined as follows:
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization.
  • NIHSS 3-5 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
  • The presence of a Target Mismatch defined as:
  • Ischemic Core < 50cc (defined on NCCT/CTP* or DWI-MRI)
  • Visual or automatedly detected hypodensity on NCCT should be used to exclude or include patients if the investigator believes that their assessment is more reliable than the CTP volume in any particular case.
  • Mismatch Volume (TMax >6sec lesion - Core volume lesion) >10cc
  • Mismatch Ratio >1.4
  • Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as the point in time the patient was last seen well (at baseline). Treatment start is defined as the time of arterial puncture.
  • Informed consent obtained from patient or acceptable patient surrogate

Who cannot join

  • Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
  • Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having no residual disabling deficits and an NIHSS score of <5 at randomization.
  • Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
  • Contra indication to imaging with MR or CT with contrast agents.
  • Infarct core >1/3 occluded territory (MCA, ACA, or PCA) qualitatively or >50 mL quantitatively (determined by NCCT, CTP or DWI).
  • Any terminal illness such that patient would not be expected to survive more than 1 year.
Show all 22Show fewer
  • Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
  • Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
  • Premorbid disability (mRS ≥3).
  • Inability to initiate endovascular treatment within 12 hours of last seen well.
  • Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
  • Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol).
  • Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count <100,000/uL.
  • Known renal failure as defined as serum creatinine levels > 3.0 mg/dL.
  • Presumed septic embolus or suspicion of bacterial endocarditis.
  • Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
  • History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
  • Subject participating in a study involving an investigational drug or device that would impact this study
  • Known pregnancy
  • Prisoner or incarceration
  • Known acute symptomatic COVID-19 infection

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Doheim, MD contact

1-516-854-0487

doheimmf@upmc.edu

Emma Gyurisin, MPH contact

4126779128

gyurisinek2@upmc.edu

United States4 sites, 4 recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Stephen Duong, 404-251-8890, stephen.duong@emory.edu

    Not yet recruiting

  • UI Health Care Medical Center

    Iowa City, Iowa, 52242

    Heena Olalde, MSN, RN, 319-356-8326, heena-olalde@uiowa.edu

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Denise McCarthy, MPPM RN, 1-878-261-6015, mccarthydj@upmc.edu

    Nirav Bhatt, MD

    Recruiting

  • ProMedica

    Toledo, Ohio, 43606

    Kathryn Scalzo, 419-291-4068, kathryn.scalzo@promedica.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase III, Randomized, Multicenter, 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 Strokes.

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

Read the detailed description

DUSK is a Phase-3, prospective, multicenter, investigational, randomized, controlled, open-label study with blinded endpoint evaluation (PROBE design) and an adaptive design with population enrichment. The randomization employs a 1:1 ratio of endovascular thrombectomy (EVT) versus standard medical management (SMM) in patients who suffer a distal medium vessel occlusion (DMVO) stroke within 12 hours from time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging. Randomization will be done under a minimization process using age (≤67 vs. >67 years), baseline NIHSS (≤12 vs. >12), use of IV thrombolysis (none vs. within 120 minutes from randomization vs. > 120 minutes from randomization), site of occlusion (M2 vs. M3 vs. ACA vs. PCA), baseline infarct volume (≤15mL vs. >15-30mL vs. >30-50mL), perfusion mismatch volume (≤15mL vs. >15-30mL vs. >30-50mL), therapeutic window (0-4.5 vs. 4.5-8 or >9-12 hours after TLKW), and participating site. The candidate enriched populations that the trial considers are based on use of intravenous thrombolysis (none vs. within 120 minutes from randomization vs. > 120 minutes from randomization), TLKW to randomization (0-6 vs. 6-12 hours) and mismatch volumes as measured using absolute mismatch (defined as Tmax>6 sec - DWI lesion on MRI or Tmax>6 sec -rCBF<30% lesion on CTP) (>40 cc vs. >30cc vs. >20cc vs. >10cc). The primary endpoint will be a categorical shift across all levels on the modified Rankin Scale (mRS) at 90-days post-randomization. The hypothesis is that EVT will lead to an improved clinical outcome at 90 days. Interim analysis will be performed after the primary endpoint is available for a total of 386 randomized patients.

Conditions
Ischemic Stroke
Being tested
Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion, Standard medical management
Keywords
Stroke, Ischemic
Medical subject headings
Ischemic Stroke, Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusionDevice

    Also called AXS Vecta 46, AXS CAT 5, NXT ProVue Retriever

    The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems, and is also indicated for use as a conduit for retrieval devices.

    The AXS Vecta Intermediate Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

    The Trevo® Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA).

  • Standard medical managementOther

    Also called Active Comparator

    All subjects should receive the best standard medical therapy based on current AHA guidelines. Subjects randomized to standard medical management (SMM) will receive standard medical therapy only based on the guidelines. All subjects are expected to be admitted to hospital as part of routine best guideline-based care and treated on a stroke unit or neurointensive care unit or equivalent.

Study groups in NCT05983757
Study groupRoleWhat they receive
Standard of Care TreatmentActive comparatorStandard medical management in patients who suffer a distal medium vessel occlusion
Receives: Other: Standard medical management
Endovascular ThrombectomyExperimentalEndovascular thrombectomy in patients who suffer a distal medium vessel occlusion.
Receives: Device: Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Modified Rankin Scale measurement (mRS): 0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead

    Measured: 90-day follow-up

Secondary outcomes (29)

  1. Shift in distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment

    Modified Rankin Scale measurement (mRS)0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead

    Measured: 90-day follow-up

  2. Rates of Independent Outcome defined as mRS ≤2 and/ or equal to Baseline mRS at 90 days

    Independant outcome: 0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead

    Measured: 90-day follow-up

  3. Rates of Excellent Outcome defined as mRS ≤1 and/ or equal to Baseline mRS at 90 days

    Excellent outcome: 0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead.

    Measured: 90-day follow-up

  4. Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following:

    NIHSS and mRS scores MRS: 0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead NIHSS: 0=no stroke symptoms, 1-4=minor stroke, 5-15 moderate stroke, 16-20 moderate to sever stroke, 21-42- severe stroke.

    • If NIHSS <10 and Baseline mRS 0 or 1: 90-day mRS ≤1
    • If NIHSS <10 and Baseline mRS 2: 90-day mRS ≤2
    • If NIHSS ≥10 and Baseline mRS 0 or 1: 90-day mRS ≤2
    • If NIHSS ≥10 and Baseline mRS 2: 90-day mRS ≤3

    Measured: 90-day follow-up

  5. EVT arm only: Final reperfusion grades according to the extended Thrombolysis in Cerebral Infarction (eTICI) scale and the rates of First Pass Effect (eTICI ≥2c) and Modified First Pass Effect (eTICI ≥2b50)

    Reprofusion grades :TICI scores:grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion).

    Measured: 90-day follow-up

  6. EVT arm only: Final reperfusion grades according to the rates of First Pass Effect (eTICI ≥2c)

    Reprofusion grades :TICI scores:grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion).

    Measured: 90-Day follow up

  7. EVT arm only: Final reperfusion grades according to the Modified First Pass Effect (eTICI ≥2b50)

    Reprofusion grades :TICI scores:grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion).

    Measured: 90 day follow up

  8. Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days

    utility weighted mRS 0=no symptoms, 1= no significant disablity despite symptoms, able to carry out all usual duties. 2= slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=moderate disability, requiring some help, able to walk without assistance. 4=moderatly severe disability, unable to walk and attend to bodily needs without assistance. 5=severe disability, bedridden, incontinent and requiring total nursing care. 6=dead

    Measured: 90-day follow-up

  9. Final infarct volume (FIV) (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)

    Infarct volume at 24 hours will be measured on CT or MRI.

    Measured: 24 hours (-2hours /+12 hours)

  10. Final infarct growth (FIV - baseline infarct on CTP or DWI)

    Infarct volume at 24 hours will be measured on CT or MRI, growth of infarct from baseline to 24 hours will be captured.

    Measured: 24 hours (-2 hours/+12 hours)

  11. Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)

    Infarct volume at 3-5 days will be measured on CT or MRI.

    Measured: 3-5 days

  12. Final infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)

    Infarct volume at 3-5 days will be measured on CT or MRI, growth of infarct will be compared to baseline.

    Measured: 3 to 5 days

  13. Clinical improvement at 24 hours calculated as the difference between 24-hour and baseline NIHSS score

    NIHSS score at 24hours :NIHSS: 0=no stroke symptoms, 1-4=minor stroke, 5-15 moderate stroke, 16-20 moderate to sever stroke, 21-42- severe stroke.

    Measured: 24 hours

  14. Cost effectiveness analysis of endovascular thrombectomy vs standard medical therapy

    Assessment of costs from the time of randomization to the 90 day follow up. This includes Costs of hospitalization, institutional living and outpatient care will be assessed and compared for each arm.

    Measured: 90-day follow-up

  15. Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)

    CT or MRI results at 24 hours

    Measured: 24 hours

  16. Vessel patency evaluated by CTA or MRA perfusion at 24 hours in both treatment groups (if available)

    CTA or MRA perfusion results at 24 hours

    Measured: 24 hours

  17. Patient reported outcomes (EQ-5D)

    Questionnaires assessed by blinded assessor at 90 days. EQ-5D measures mobility, self care, usual activities, pain and anxiety, overall heath is measured on a scale of 0 (worst health state) to 100 best health state.

    Measured: 90-day follow-up

  18. Patient reported outcomes (PROMIS Global-10)

    Questionnaires assessed by blinded assessor at 90 days. Promise Global Health measures current health status on a scale of 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. The scale is from 1-5 with 1 being the poorest health outcome and 5 the best.

    Measured: 90 day follow up

  19. Patient reported outcomes (PROMIS Fatigue)

    Questionnaires assessed by blinded assessor at 90 days. Promise Fatigue will measure degree of fatigue on a scale of 1=not at all, 2=a little bit, 3=somewhat, 4= quite a bit, 5=very much. The scale is from 1-5 with 1 being the least fatigued and 5 the greatest feeling of fatigue.

    Measured: 90 day follow up

  20. Patient reported outcomes ( IADL)

    Questionnaires assessed by blinded assessor at 90 days. IADL measures the ability to use a telephone, shop prepare food, do housekeeping, laundry, mode of transportation, medications and handle finances. The subject will answer the questions and answer as for how they are able to accomplish their ADLs.

    Measured: 90 day follow up

  21. Patient reported outcomes ( MoCa)

    Questionnaires assessed by blinded assessor at 90 days. MoCa measures the patient's ability to draw(visuospatial), name items, memory, attention, language, and abstraction. There are several questions that the subject will answer for each category.

    Measured: 90 day follow up

  22. All cause mortality

    All-cause mortality within 90 days

    Measured: 90 day follow up

  23. Mortality due to stroke

    Mortality within 90 days due to index stroke

    Measured: 90 day follow up

  24. Intracranial hemorrhage

    Symptomatic intracranial hemorrhage (SICH) defined as per the Heidelberg Classification: new intracranial hemorrhage detected by brain imaging associated with any of the item below:

    • ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening.
    • ≥2 point in one NIHSS category.
    • Absence of alternative explanation for deterioration. This will be the primary definition for SICH as per the recommendation of both the FDA and DSMB.
    • Symptomatic intracranial hemorrhage (SICH) defined as per the modified SITS-MOST definition.

    Measured: 90 day follow up

  25. Intracranial hemorrhage

    The incidence of any intracranial hemorrhage measured at 24 (-2/+12) hours as graded by the central core-lab using the Heidelberg classification criteria.

    Measured: 24 hours (-2 hours /+12 hours)

  26. Procedure-related vessel perforation.

    Perforation of the artery related to the procedure.

    Measured: 24 hours (-2 hours /+12 hours)

  27. Procedure-related vessel dissection

    Dissection of an artery related to the procedure.

    Measured: 24 hours (-2 hours/+12 hours)

  28. Embolization to a new territory during mechanical thrombectomy (MT) procedure

    New emboli to a different area of the brain during the MR procedure.

    Measured: 24 hours (-2 hours/+12hours)

  29. Significant extracranial hemorrhage (e.g., access site, retroperitoneal hematoma) requiring blood transfusion and/or surgical intervention.

    Hemorrhage in other areas besides the brain such as the arterial access site or retroperitoneum.

    Measured: 24 hours (-2 hours/+12 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start2 Apr 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The randomization employs a 1:1 ratio of endovascular thrombectomy (EVT) with the use of Trevo NXT ProVue Retrievers, AXS Vecta 46 Intermediate Catheter and AXS Catalyst 5 Distal Access Catheter, versus standard medical management (SMM) in patients who suffer a distal medium vessel occlusion (DMVO) stroke within 12 hours from time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging. Randomization will be done under a minimization process using age (≤67 vs. \>67 years), baseline NIHSS (≤12 vs. \>12), use of IV thrombolysis (none vs. within 120 minutes from randomization vs. \> 120 minutes from randomization), site of occlusion (M2 vs. M3 vs. ACA vs. PCA), baseline infarct volume (≤15mL vs. \>15-30mL vs. \>30-50mL), perfusion mismatch volume (≤15mL vs. \>15-30mL vs. \>30-50mL), therapeutic window (0-4.5 vs. 4.5-8 or \>9-12 hours after TLKW), and participating site.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
584 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983757
Sponsor's protocol ID
STUDY23030032
Acronym
DUSK
Status last verified
Feb 2026
First submitted
20 Jul 2023
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ospel JM, Goyal M. A review of endovascular treatment for medium vessel occlusion stroke. J Neurointerv Surg. 2021 Jul;13(7):623-630. doi: 10.1136/neurintsurg-2021-017321. Epub 2021 Feb 26.

    PubMed 33637570

  • Saver JL, Chapot R, Agid R, Hassan A, Jadhav AP, Liebeskind DS, Lobotesis K, Meila D, Meyer L, Raphaeli G, Gupta R; Distal Thrombectomy Summit Group*dagger. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. 2020 Sep;51(9):2872-2884. doi: 10.1161/STROKEAHA.120.028956. Epub 2020 Aug 6. No abstract available.

    PubMed 32757757

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

    PubMed 31662037

  • Turc G, Bhogal P, Fischer U, Khatri P, Lobotesis K, Mazighi M, Schellinger PD, Toni D, de Vries J, White P, Fiehler J. European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic StrokeEndorsed by Stroke Alliance for Europe (SAFE). Eur Stroke J. 2019 Mar;4(1):6-12. doi: 10.1177/2396987319832140. Epub 2019 Feb 26.

    PubMed 31165090

  • Campbell BCV, Ma H, Ringleb PA, Parsons MW, Churilov L, Bendszus M, Levi CR, Hsu C, Kleinig TJ, Fatar M, Leys D, Molina C, Wijeratne T, Curtze S, Dewey HM, Barber PA, Butcher KS, De Silva DA, Bladin CF, Yassi N, Pfaff JAR, Sharma G, Bivard A, Desmond PM, Schwab S, Schellinger PD, Yan B, Mitchell PJ, Serena J, Toni D, Thijs V, Hacke W, Davis SM, Donnan GA; EXTEND, ECASS-4, and EPITHET Investigators. Extending thrombolysis to 4.5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data. Lancet. 2019 Jul 13;394(10193):139-147. doi: 10.1016/S0140-6736(19)31053-0. Epub 2019 May 22.

    PubMed 31128925

  • Ospel JM, Menon BK, Demchuk AM, Almekhlafi MA, Kashani N, Mayank A, Fainardi E, Rubiera M, Khaw A, Shankar JJ, Dowlatshahi D, Puig J, Sohn SI, Ahn SH, Poppe A, Calleja A, Hill MD, Goyal M. Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment. Stroke. 2020 Nov;51(11):3232-3240. doi: 10.1161/STROKEAHA.120.030227. Epub 2020 Oct 19.

    PubMed 33070714

  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PubMed 26898852

  • Menon BK, Hill MD, Davalos A, Roos YBWEM, Campbell BCV, Dippel DWJ, Guillemin F, Saver JL, van der Lugt A, Demchuk AM, Muir K, Brown S, Jovin T, Mitchell P, White P, Bracard S, Goyal M. Efficacy of endovascular thrombectomy in patients with M2 segment middle cerebral artery occlusions: meta-analysis of data from the HERMES Collaboration. J Neurointerv Surg. 2019 Nov;11(11):1065-1069. doi: 10.1136/neurintsurg-2018-014678. Epub 2019 Apr 11.

    PubMed 30975736

  • Haussen DC, Lima A, Nogueira RG. The Trevo XP 3x20 mm retriever ('Baby Trevo') for the treatment of distal intracranial occlusions. J Neurointerv Surg. 2016 Mar;8(3):295-9. doi: 10.1136/neurintsurg-2014-011613. Epub 2015 May 6.

    PubMed 25948592

  • Haussen DC, Al-Bayati AR, Eby B, Ravindran K, Rodrigues GM, Frankel MR, Nogueira RG. Blind exchange with mini-pinning technique for distal occlusion thrombectomy. J Neurointerv Surg. 2020 Apr;12(4):392-395. doi: 10.1136/neurintsurg-2019-015205. Epub 2019 Aug 31.

    PubMed 31473647

  • Perez-Garcia C, Moreu M, Rosati S, Simal P, Egido JA, Gomez-Escalonilla C, Arrazola J. Mechanical Thrombectomy in Medium Vessel Occlusions: Blind Exchange With Mini-Pinning Technique Versus Mini Stent Retriever Alone. Stroke. 2020 Nov;51(11):3224-3231. doi: 10.1161/STROKEAHA.120.030815. Epub 2020 Oct 19.

    PubMed 33070712

  • Grossberg JA, Rebello LC, Haussen DC, Bouslama M, Bowen M, Barreira CM, Belagaje SR, Frankel MR, Nogueira RG. Beyond Large Vessel Occlusion Strokes: Distal Occlusion Thrombectomy. Stroke. 2018 Jul;49(7):1662-1668. doi: 10.1161/STROKEAHA.118.020567. Epub 2018 Jun 18.

    PubMed 29915125

  • Nogueira RG, Mohammaden MH, Haussen DC, Budzik RF, Gupta R, Krajina A, English JD, Malek AR, Sarraj A, Narata AP, Taqi MA, Frankel MR, Miller TR, Grobelny T, Baxter BW, Bartolini BM, Jenkins P, Estrade L, Liebeskind D, Veznedaroglu E; Trevo Registry Investigators. Endovascular therapy in the distal neurovascular territory: results of a large prospective registry. J Neurointerv Surg. 2021 Nov;13(11):979-984. doi: 10.1136/neurintsurg-2020-016851. Epub 2020 Dec 15.

    PubMed 33323503

  • Goyal M, Ospel JM, Menon BK, Hill MD. MeVO: the next frontier? J Neurointerv Surg. 2020 Jun;12(6):545-547. doi: 10.1136/neurintsurg-2020-015807. Epub 2020 Feb 14. No abstract available.

    PubMed 32060151

  • Seners P, Turc G, Maier B, Mas JL, Oppenheim C, Baron JC. Incidence and Predictors of Early Recanalization After Intravenous Thrombolysis: A Systematic Review and Meta-Analysis. Stroke. 2016 Sep;47(9):2409-12. doi: 10.1161/STROKEAHA.116.014181. Epub 2016 Jul 26.

    PubMed 27462117

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion and Standard medical management in people with Ischemic Stroke, run by Raul Nogueira at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Doheim, MD (1-516-854-0487, doheimmf@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 90-day follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05983757, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in