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

• Sponsor: Hui-Sheng Chen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04664933
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic; Intravascular Thrombosis; Mechanical Thrombectomy	Drug: Intra-arterial administration of neuroprotective agents	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of server adverse events [48 hours]

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

Secondary Outcome Measures

1. Proportion of patients with modified Rankin Score 0 to 1 [90 days]

   Proportion of patients with modified Rankin Score 0 to 1

2. Proportion of patients with modified Rankin Score 0 to 2 [90 days]

   Proportion of patients with modified Rankin Score 0 to 2

3. Modified Rankin Score [90 days]

   Modified Rankin Score

4. Decrease in national institutes of health stroke scale (NIHSS) [48 hours]

   Decrease in NIHSS scoring at 48 hours after the treatment

5. Proportion of symptomatic intracranial hemorrhage (sICH) [48 hours]

   sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

6. Proportion of intraparenchymal hemorrhage (PH1 and PH2) [48 hours]

   Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment

7. Changes in cerebral edema [48 hours]

   Cerebral edema was determined by cerebral volume or midline shift

Other Outcome Measures

1. Differences in serum factors levels and blood gas in diverse vessel region [Hour 0]

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

2. Changes in serum factors levels [30 minutes, 24 hours]

   changes in serum factors levels before and at different timepoints after recanalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, General Hospital of Northern Theater Command	Shenyang		China	110016

Sponsors and Collaborators

• Hui-Sheng Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Director, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT04664933
• Other Study ID Numbers: K (2020) 32
• First Posted: Dec 11, 2020
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Thrombosis; Ischemia; Neuroprotective Agents

Study Results

No Results Posted as of Aug 3, 2022