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

Not Applicable

Active, not recruiting

• Conditions: Ischemic Stroke; Neuroprotection
• Interventions: Drug: Intra-arterial administration of neuroprotective agents

• Registration Number: NCT04664946
• Lead Sponsor: Hui-Sheng Chen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study Start: 2020-12-01
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-arterial administration of 3-n-butylphthalide	Intra-arterial administration of neuroprotective agents	Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.

Primary Outcome Measures

Name	Time	Method
Proportion of server adverse events	48 hours	server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0 to 1	90 days	Proportion of patients with modified Rankin Score 0 to 1
Modified Rankin Score	90 days	Modified Rankin Score
Proportion of patients with modified Rankin Score 0 to 2	90 days	Proportion of patients with modified Rankin Score 0 to 2
Changes in cerebral edema	48 hours	Cerebral edema was determined by cerebral volume or midline shift
All causes of death within 48 hours after the treatment	48 hours	All causes of death within 48 hours after the treatment
Differences in serum factors levels in different artery region	0 hour	Differences in serum factors levels in different Bessel region before recanalization
Decrease in national institutes of health stroke scale (NIHSS)	48 hours	Decrease in NIHSS scoring at 48 hours after the treatment
Proportion of symptomatic intracranial hemorrhage (sICH)	48 hours	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Proportion of intraparenchymal hemorrhage (PH1 and PH2)	48 hours	Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China