ClinicalTrials.gg
RecruitingNCT06633809TEMPOSUpdated Oct 9, 2024

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

An observational study in Stroke, Acute, Cerebrovascular Disorders and Brain Diseases, sponsored by Sir Run Run Shaw Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.

Primary conditionBrain InfarctionRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Brain Infarction
Why
  1. The study's listed conditions name Brain Infarction, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sir Run Run Shaw Hospital · Observational

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

Read the detailed description

It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.

02

Conditions studied

  • Stroke, Acute
  • Cerebrovascular Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Vascular Diseases
  • Brain Infarction
  • Nervous System Diseases

Keywords

  • stroke
  • Mechanical thrombectomy
  • Proximal intracranial arterial occlusions
  • Large vessel occlusion
  • acute neurological deterioration
  • Outcome
03

In context

Brain Infarction Reclassified

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's planned enrollment of 200 is below the median of 477 across 23 observational studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.

Compared within Brain Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Acute ischemic stroke patients with minor stroke (NIHSS 0-5) and large artery occlusion.

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. Aged 18 years or older
  2. Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
  3. Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
  4. Baseline ASPECTS ≥6 or infarct Core Volume of \< 70 on NCCT/DWI/CTP
  5. Pre-mRS≤1

Exclusion criteria

Exclusion Criteria:

  1. Any sign of intracranial hemorrhage on baseline CT/MR;
  2. Seizures at stroke onset
  3. Baseline blood glucose of \<2.78 mmol or >22.20 mmol, or count \< 100,000/uL or serum creatinine levels > 3.0 mg/dL
  4. Participation in any study in the previous 30 days
Terms in these criteria, in plain language(2)

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.

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Immediate Endovascular Therapy

    The immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used.

    Other: Immediate endovascular therapy

  • Best Medical Therapy

    The best medical therapy is standard medical therapy, including intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT including any endovascular therapies. The rescue endovascular therapies may be performed in case of acute neurological deterioration.

Interventions

  • OtherImmediate endovascular therapy

    The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.

    Also known as: Best medical therapy

06

What researchers measure

Primary outcomes

  1. modified Rankin Scale at 90 days

    modified Rankin Scale at 90 days

    Time frame: 90 days

  2. acute neurological deterioration

    It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

    Time frame: 24 hours

Secondary outcomes

  1. Incidence of symptomatic intracerebral hemorrhage

    Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria

    Time frame: 2-3 days

  2. patients with good outcome comparing the two treatment groups

    Good outcome is defined as a score of 0-2 on the 90-day mRS

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06633809
Responsible party
Jinhua Zhang (Prof., Sir Run Run Shaw Hospital) — Principal investigator
First posted
Oct 9, 2024
Start date
Nov 22, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Oct 9, 2024

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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