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

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study

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

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Mechanical Thrombectomy; Intravascular Thrombosis
• Intervention / Treatment: Drug: Intra-arterial administration of neuroprotective agents

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of server adverse events	server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Proportion of patients with modified Rankin Score 0 to 1	Proportion of patients with modified Rankin Score 0 to 1	90 days
Proportion of patients with modified Rankin Score 0 to 2	Proportion of patients with modified Rankin Score 0 to 2	90 days
Modified Rankin Score	Modified Rankin Score	90 days
Decrease in national institutes of health stroke scale (NIHSS)	Decrease in NIHSS scoring at 48 hours after the treatment	48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)	Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment	48 hours
Changes in cerebral edema	Cerebral edema was determined by cerebral volume or midline shift	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in serum factors levels and blood gas in diverse vessel region	Differences in serum factors levels and blood gas in diverse vessel region	Hour 0
Changes in serum factors levels	changes in serum factors levels before and at different timepoints after recanalization	30 minutes, 24 hours

Collaborators and Investigators

• Sponsor: Hui-Sheng Chen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Stroke; Ischemic Stroke; Ischemia; Thrombosis; Physiological Effects of Drugs; Protective Agents; Neuroprotective Agents
• Other Study ID Numbers: K (2020) 32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No