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RecruitingNCT05634382Updated Feb 14, 2023

Endovascular Thrombectomy With and Without Intravenous Thrombolysis in Extended Time Window

A Phase 3 interventional study of Intravenous thrombolysis agents and endovascular thrombectomy in Stroke, Acute Ischemic, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary hypothesis being tested in this trial is that ischemic stroke patients in large vessel occlusion of anterior circulation at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given endovascular thrombectomy with intravenous thrombolysis compared with that of given direct endovascular thrombectomy alone.

Read the detailed description

A number of multicenter randomized controlled trials have provided evidence supporting the application of endovascular therapy for acute ischemic stroke with anterior circulation large vessel occlusion. However, whether intravenous thrombolysis is necessary before endovascular therapy is still controversial. The combined trial data (including DEVT, DIRECT-MT, MR-CLEAN NO-IV and SKIP) assessing direct mechanical thrombectomy versus bridging therapy showed no difference in improving good functional outcome. However, a recent observational cohort study of 15832 patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes after adjusting for other covariates.

The 2019 AHA/ASA guidelines for the early management of patients with ischemic stroke states that mechanical thrombectomy is recommended for patients with anterior circulation large vessel occlusion within 6-24 hours of last known normal who meet the DWAN or DEFUSE-3 criteria (level I recommendation, level A evidence). The DEFUSE 3 perfusion-infarction core mismatch criteria is: core infarct volume \<70mL, ischemic penumbra volume >15mL, and hypoperfusion volume/core infarct volume >1.8. Intravenous thrombolytic therapy is recommended for patients with ischemic stroke within 4.5 hours of onset. A meta-analysis of three randomized controlled trials recently published in the Lancet found that ischemic stroke at 4.5 to 9 hours of onset or wake stroke was consistent with a core infarct volume \<70mL, a penumbra volume >10mL, and a hypoperfusion volume/core infarct volume >1.2. Benefit from intravenous thrombolytic therapy (3 month mRS 0-1 ratio, thrombolytic vs non-thrombolytic: 36% vs 29%). It was also strongly recommended by 2021 ESO guidelines on intravenous thrombolysis for acute ischemic stroke.

For these reasons the investigators hypothesize that endovacular thrombectomy bridging with intravenous thrombolysis is superior to direct thrombectomy in patients of stroke at 4.5 to 9 hours, guided with perfusion imaging.

02

Conditions studied

  • Stroke, Acute Ischemic
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 222 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

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

Inclusion criteria

  1. Patient/Legally Authorized Representative has signed the Informed Consent form
  2. Age ≥ 18
  3. Clinical signs consistent with an acute ischemic stroke
  4. Neurological deficit with a NIHSS of ≥ 6 (deficits judged to be clearly disabling at presentation)
  5. Patient is eligible for intravenous thrombolysis
  6. Patient is eligible for endovascular treatment
  7. Randomization no later than 8 hours 45 minutes after stroke symptom onset and initiation of IV t-PA must be started within 9 hours of stroke symptoms onset (for stroke with unknown time of onset, the midpoint of the time last known to be well and symptom recognition time)
  8. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA (including the reconstructed CTA derived from CTP). And target Mismatch Profile on CT perfusion or MRI (ischemic core volume is \< 70 ml, mismatch ratio is >/= 1.8 and mismatch volume is >/= 15 ml)
  9. Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)

Exclusion criteria

Exclusion Criteria:

  1. Acute intracranial hemorrhage
  2. Any contraindication for IV t-PA
  3. Pre-treatment with IV t-PA
  4. Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
  5. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
  6. Known current participation in a clinical trial (investigational drug or medical device)
  7. Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) \< 30 mL/min or requirement for hemodialysis or peritoneal dialysis
  8. Severe comorbid condition with life expectancy less than 90 days at baseline
  9. Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
  10. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  11. Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
  12. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
  13. Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
  14. Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
  15. Radiological confirmed evidence of cerebral vasculitis
  16. CTA or MRA evidence of carotid artery dissection
  17. Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
222 participants (estimated)

Study arms

  • Experimental
    Intravenous thrombolysis bridging with endovascular thrombectomy

    Drug: Intravenous thrombolysis agents · Procedure: endovascular thrombectomy

  • Active comparator
    Direct endovascular thrombectomy without intravenous thrombolysis

    Procedure: endovascular thrombectomy

Interventions

  • DrugIntravenous thrombolysis agents

    Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA,alteplase) or TNK-tPA (Tenecteplase,Metalyse)

  • Procedureendovascular thrombectomy

    endovascular mechanical thrombectomy with nonspecific device

06

What researchers measure

Primary outcomes

  1. Good clinical outcome

    Score in modified Rankin Scale (mRS) ≤ 2 (mRS is short for modified ranking score, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)

    Time frame: 90 days after randomization

Secondary outcomes

  1. Mortality

    Mortality due to any cause

    Time frame: 90 days after randomization

  2. Modified Rankin Scale (mRS) shift analysis

    (mRS is short for National Institute of health stroke scale, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)

    Time frame: day 0 and 90 days after randomization

  3. National Institute of Health Score Scale (NIHSS)

    (NIHSS is short for modified ranking score, with minimum value of 0 and maximum value of 42. Higher score means a worse outcome.)

    Time frame: day 0 and day 1 after randomization

  4. Thrombolysis in Cerebral Infarction (TICI) scale

    TICI is for "Thrombolysis in cerebral Infarction", with minimum value of 0 and maximum value of 3. Higher score means a better reperfusion state.

    Time frame: day 0 and day 1 after randomization

  5. Serious adverse events

    Leading to death or prolonged hospitalisation

    Time frame: day 0 until 90 days after randomization

  6. Intracranial hemorrhage

    Hemorrhagic finding on CT or MRI

    Time frame: day 1 after randomization

  7. Quality of life assessed by questionnaire

    Include but not limited to the Barthelindex of ADL, which is the abbreviation of " activities of daily living", with minimum value of 0 and maximum value of 100. Higher score means a worse outcome.

    Time frame: 90 days after randomization

  8. Overall costs incurred during hospitalisation

    include charges and expenses of every description

    Time frame: 90 days after randomization

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05634382
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Dec 2, 2022
Start date
Dec 3, 2022
Primary completion
Nov 28, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Feb 14, 2023

Study contacts

Yi Chen, Doctor
Contact
ileen@163.com
08657113588187112
Min Lou, Professor
principal investigator · Zhejiang University

Oversight

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

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