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

NCT04664933 | Recruiting DMC

• 1 other identifier: K (2020) 32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke, Ischemic; Intravascular Thrombosis; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of server adverse events

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

  48 hours

Secondary Outcomes (7)

• Proportion of patients with modified Rankin Score 0 to 1

  90 days

• Proportion of patients with modified Rankin Score 0 to 2

  90 days

• Modified Rankin Score

  90 days

• Decrease in national institutes of health stroke scale (NIHSS)

  48 hours

• Proportion of symptomatic intracranial hemorrhage (sICH)

  48 hours

Other Outcomes (2)

• Differences in serum factors levels and blood gas in diverse vessel region

  Hour 0

• Changes in serum factors levels

  30 minutes, 24 hours

Study Arms (1)

Intra-arterial administration of 3-n-butylphthalide

EXPERIMENTAL

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.

Drug: Intra-arterial administration of neuroprotective agents

Interventions

Intra-arterial administration of neuroprotective agents 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

Intra-arterial administration of 3-n-butylphthalide

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Modified Rankin Score \>2 caused by a history of prior stroke;
• Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<80000/mm3);
• 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;
• Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
• Unsuitable for this clinical studies assessed by researcher.

Sponsors & Collaborators

• Hui-Sheng Chen: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)