Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

NCT06143488 — Not applicable, Recruiting, 264 participants, First Affiliated Hospital of Wannan Medical College

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RegistryNCT06143488
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment264 (Estimated)
SponsorFirst Affiliated Hospital of Wannan Medical College (Other)
ConditionsAcute Ischemic Stroke, Mild Neurocognitive Disorder, Thrombectomy
InterventionsEndovascular therapy, Best medical management (Procedure, drug)
Datesstart 2024-01-21, primary completion 2027-12-31 (estimated), completion 2028-03-31 (estimated), first posted 2023-11-22, last updated 2026-09-25
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Acute Ischemic Stroke All trials for Mild Neurocognitive Disorder All trials of Endovascular therapy All trials of Best medical management

-Summary

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END).

Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials.

The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

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+Arms and interventions

ArmTypeInterventionsDescription
EVT groupExperimentalProcedure: Endovascular therapyIn the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice.
Best medical managementActive comparatorProcedure: Endovascular therapy; Drug: Best medical managementAll the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
  • Endovascular therapy (Procedure): Drug: Best medical management All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Procedure: Endovascular therapy In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.
  • Best medical management (Drug): All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.

+Outcome measures

Primary outcomes

  • 90-day excellent clinical outcome [90±7 days after randomization]: modified Rankin scale score: 0-1; , 0 \[no disablility\] to 6 \[death\]

Secondary outcomes

  • Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard [within 48 hours after randomization]: Heidelberg standard was defined as 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. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
  • All-cause mortality rate [90±7 days after randomization]: All-cause mortality rate
  • Good clinical outcome [90±7 days after randomization]: modified Rankin Scale score: 0-2; 0 \[no disablility\] to 6 \[death\]
  • 90-day ordinal modified Rankin Scale score shift [90±7 days after randomization]: ordinal modified Rankin Scale score shift; 0 \[no disablility\] to 6 \[death\]
  • Rates of early neurological deterioration [at 24 hours, 72 hours, and 7 days/discharge]: early neurological deterioration during hospitalization
  • EuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire score [90±7 days after randomization]: Score range from -0.39 to 1.00, with higher scores indicating better quality of life

Other outcomes

  • incidence of adverse events [within 7 days after randomization]: Any ICH post-randomization; vessel perforation; embolus migration in a new territory; rescue endovascular treatment; acute coronary syndrome, venous thrombosis or embolus events; brain herniation, and pneumonia, respiratory failure, circulatory failure, stress ulcers, renal failure, etc.

+Eligibility

Sex: All, ages: 18 Years to any

1. Aged 18 years or older;
2. The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
3. Low NIHSS score (2-5 points), with at least one of the following items:

   1. Altered mental status (lethargy or worse);
   2. Facial palsy (facial weakness score ≥ 1 point);
   3. Motor dysfunction (limb weakness score ≥ 1 point);
   4. Aphasia (language disturbance score ≥ 1 point);
   5. Hemispatial neglect (neglect score ≥ 1 point);
4. Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
5. All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
6. Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.

+Locations (1)

FacilityCityCountryStatus
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical CollegeWuhu, AnhuiChinaRecruiting