Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)

Ischemic Stroke Clinical Trial

Official title:

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04664946
• Other study ID #: k(2020)31
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: August 2023
• 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 missed recanalization operation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. Major neurologic deficits: 6=NIHSS=20;

3. Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4);

4. Premorbid mRS 0 or 1;

5. Signed informed consent.

Exclusion Criteria:

1. Modified Rankin Score >2 caused by a history of prior stroke;

2. Patients who underwent intravenous thrombolysis or Endovascular treatment;

3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <80000/mm3;

4. 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;

5. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);

6. Unsuitable for this clinical studies assessed by researcher.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Neuroprotection
• Stroke

Intervention

Drug:
• Intra-arterial administration of neuroprotective agents
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 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
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
Secondary	All causes of death within 48 hours after the treatment	All causes of death within 48 hours after the treatment	48 hours
Secondary	Differences in serum factors levels in different artery region	Differences in serum factors levels in different Bessel region before recanalization	0 hour