Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2026-05-31

Brief Summary

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To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.

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Detailed Description

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Conditions

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Stroke, Ischemic Intravascular Thrombosis Mechanical Thrombectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intra-arterial administration of 3-n-butylphthalide

Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min.

Group Type EXPERIMENTAL

Intra-arterial administration of neuroprotective agents

Intervention Type DRUG

Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min

Interventions

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Intra-arterial administration of neuroprotective agents

Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years;
2. Acute ischemic stroke patients who is eligible for endovascular treatment;
3. Signed informed consent.

Exclusion Criteria

1. Modified Rankin Score \>2 caused by a history of prior stroke;
2. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<80000/mm3);
3. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
4. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
5. Unsuitable for this clinical studies assessed by researcher.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No