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

Hui-Sheng Chen

Status: Enrolling

Conditions: Intravascular Thrombosis; Mechanical Thrombectomy; Stroke, Ischemic

Treatments: Drug: Intra-arterial administration of neuroprotective agents

Study type: Interventional

Funder types: Other

Identifiers

NCT04664933

K (2020) 32

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intra-arterial administration of 3-n-butylphthalide

Experimental group

Description:

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.

Treatment:

Drug: Intra-arterial administration of neuroprotective agents