Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

NCT06633809 | Recruiting

• 1 other identifier: 20210607-34
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• modified Rankin Scale at 90 days

  modified Rankin Scale at 90 days

  90 days

• 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.

  24 hours

Secondary Outcomes (2)

• Incidence of symptomatic intracerebral hemorrhage

  2-3 days

• patients with good outcome comparing the two treatment groups

  90 days

Study Arms (2)

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

Immediate endovascular therapy OTHER

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

Also known as: Best medical therapy

Immediate Endovascular Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any sign of intracranial hemorrhage on baseline CT/MR;
• Seizures at stroke onset
• Baseline blood glucose of \<2.78 mmol or \>22.20 mmol, or platelet count \< 100,000/uL or serum creatinine levels \> 3.0 mg/dL
• Participation in any investigational study in the previous 30 days

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Brain Infarction; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 22, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)