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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664933
• Other study ID #: K (2020) 32
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intravascular Thrombosis
• Ischemia
• Ischemic Stroke
• Mechanical Thrombectomy
• Stroke
• Stroke, Ischemic
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes in serum factors levels	changes in serum factors levels before and at different timepoints after recanalization	30 minutes, 24 hours
Primary	Proportion of server adverse events	server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.	48 hours
Secondary	Proportion of patients with modified Rankin Score 0 to 1	Proportion of patients with modified Rankin Score 0 to 1	90 days
Secondary	Proportion of patients with modified Rankin Score 0 to 2	Proportion of patients with modified Rankin Score 0 to 2	90 days
Secondary	Modified Rankin Score	Modified Rankin Score	90 days
Secondary	Decrease in national institutes of health stroke scale (NIHSS)	Decrease in NIHSS scoring at 48 hours after the treatment	48 hours
Secondary	Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Secondary	Proportion of intraparenchymal hemorrhage (PH1 and PH2)	Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment	48 hours
Secondary	Changes in cerebral edema	Cerebral edema was determined by cerebral volume or midline shift	48 hours