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RecruitingNCT05983757DUSKUpdated Feb 23, 2026

Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe

An interventional study of Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion and Standard medical management in Ischemic Stroke, sponsored by Raul Nogueira. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Raul Nogueira · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
584
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • Stroke
  • Ischemic
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 584 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

This is the only study on the registry with Raul Nogueira as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years (no upper age limit)

  2. 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.

  3. 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.)*
  4. No significant pre-stroke functional disability (mRS ≤2)

  5. Evidence of a disabling stroke defined as follows:

    1. Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization.
    2. 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.

  6. The presence of a Target Mismatch defined as:

    1. 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.

    2. Mismatch Volume (TMax >6sec lesion - Core volume lesion) >10cc
    3. Mismatch Ratio >1.4
  7. 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.
  8. obtained from patient or acceptable patient surrogate

Exclusion criteria

Exclusion Criteria:

  1. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
  2. 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.
  3. 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.
  4. Contra indication to imaging with MR or CT with contrast agents.
  5. Infarct core >1/3 occluded territory (MCA, ACA, or PCA) qualitatively or >50 mL quantitatively (determined by NCCT, CTP or DWI).
  6. Any terminal illness such that patient would not be expected to survive more than 1 year.
  7. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
  8. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
  9. Premorbid disability (mRS ≥3).
  10. Inability to initiate endovascular treatment within 12 hours of last seen well.
  11. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
  12. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol).
  13. Known history of hereditary or acquired hemorrhagic diathesis and/or count \<100,000/uL.
  14. Known renal failure as defined as serum creatinine levels > 3.0 mg/dL.
  15. Presumed septic embolus or suspicion of bacterial endocarditis.
  16. 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.
  17. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  18. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
  19. Subject participating in a study involving an drug or device that would impact this study
  20. Known pregnancy
  21. Prisoner or incarceration
  22. Known acute symptomatic COVID-19 infection
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
584 participants (estimated)

Study arms

  • Active comparator
    Standard of Care Treatment

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

    Other: Standard medical management

  • Experimental
    Endovascular Thrombectomy

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

    Device: Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion

Interventions

  • DeviceExperimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion

    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).

    Also known as: AXS Vecta 46, AXS CAT 5, NXT ProVue Retriever

  • OtherStandard medical management

    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.

    Also known as: Active Comparator

06

What researchers measure

Primary outcomes

  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

    Time frame: 90-day follow-up

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 90 day follow up

  22. All cause mortality

    All-cause mortality within 90 days

    Time frame: 90 day follow up

  23. Mortality due to stroke

    Mortality within 90 days due to index stroke

    Time frame: 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.

    Time frame: 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.

    Time frame: 24 hours (-2 hours /+12 hours)

  26. Procedure-related vessel perforation.

    Perforation of the artery related to the procedure.

    Time frame: 24 hours (-2 hours /+12 hours)

  27. Procedure-related vessel dissection

    Dissection of an artery related to the procedure.

    Time frame: 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.

    Time frame: 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.

    Time frame: 24 hours (-2 hours/+12 hours)

07

Study locations

3 of 4 sites recruiting
08

References and documents

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 ↗
  • Menon BK, Al-Ajlan FS, Najm M, Puig J, Castellanos M, Dowlatshahi D, Calleja A, Sohn SI, Ahn SH, Poppe A, Mikulik R, Asdaghi N, Field TS, Jin A, Asil T, Boulanger JM, Smith EE, Coutts SB, Barber PA, Bal S, Subramanian S, Mishra S, Trivedi A, Dey S, Eesa M, Sajobi T, Goyal M, Hill MD, Demchuk AM; INTERRSeCT Study Investigators. Association of Clinical, Imaging, and Thrombus Characteristics With Recanalization of Visible Intracranial Occlusion in Patients With Acute Ischemic Stroke. JAMA. 2018 Sep 11;320(10):1017-1026. doi: 10.1001/jama.2018.12498. PubMed 30208455 ↗
  • Tian H, Parsons MW, Levi CR, Lin L, Aviv RI, Spratt NJ, Butcher KS, Lou M, Kleinig TJ, Bivard A. Influence of occlusion site and baseline ischemic core on outcome in patients with ischemic stroke. Neurology. 2019 Jun 4;92(23):e2626-e2643. doi: 10.1212/WNL.0000000000007553. Epub 2019 May 1. PubMed 31043475 ↗
  • Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, Harris GJ, Halpern EF, Koroshetz WJ, Smith WS, Nogueira RG. Prognosis of untreated strokes due to anterior circulation proximal intracranial arterial occlusions detected by use of computed tomography angiography. JAMA Neurol. 2014 Feb;71(2):151-7. doi: 10.1001/jamaneurol.2013.5007. PubMed 24323077 ↗
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Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jul 2027, 39 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 39 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2023
First posted
Aug 9, 2023
StartActual
Apr 2, 2024
Primary completionEst.
Jul 2027
CompletionEst.
Nov 2027
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05983757
Lead sponsor
Raul Nogueira
Collaborators
Stryker Neurovascular, Brainstorme Imaging Core Lab Inc
Responsible party
Raul Nogueira (Director, UPMC Stroke Institute, University of Pittsburgh) — Sponsor-investigator
First posted
Aug 9, 2023
Start date
Apr 2, 2024
Primary completion
Jul 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Feb 23, 2026

Study contacts

Mohamed Doheim, MD
Contact
doheimmf@upmc.edu
1-516-854-0487
Emma Gyurisin, MPH
Contact
gyurisinek2@upmc.edu
4126779128
Raul G Nogueira, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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