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

Hui-Sheng Chen30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke, Ischemic Intravascular Thrombosis Mechanical Thrombectomy

Interventions

Intra-arterial administration of neuroprotective agentsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

RECRUITING

Outcomes

Primary Outcomes

Proportion of server adverse events

server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.

Time frame: 48 hours

Secondary Outcomes

Proportion of patients with modified Rankin Score 0 to 1

Time frame: 90 days

Proportion of patients with modified Rankin Score 0 to 2

Time frame: 90 days

Modified Rankin Score

Time frame: 90 days

Decrease in national institutes of health stroke scale (NIHSS)

Decrease in NIHSS scoring at 48 hours after the treatment

Time frame: 48 hours

Proportion of symptomatic intracranial hemorrhage (sICH)

sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

Time frame: 48 hours

Proportion of intraparenchymal hemorrhage (PH1 and PH2)

Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment

Time frame: 48 hours

Changes in cerebral edema

Cerebral edema was determined by cerebral volume or midline shift

Time frame: 48 hours

Data from ClinicalTrials.gov

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