Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHui-Sheng Chen
About this trial
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Acute ischemic stroke patients who is eligible for endovascular treatment;
Signed informed consent.
Disqualifiers
Modified Rankin Score >2 caused by a history of prior stroke;
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<80000/mm3);
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;
Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
Trial design
Design model
Single group
Treatments tested in this trial
Intra-arterial administration of neuroprotective agents
DrugIntra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intra-arterial administration of 3-n-butylphthalideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of server adverse events
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
Time frame
48 hoursSecondary outcomes
1
Proportion of patients with modified Rankin Score 0 to 1
Proportion of patients with modified Rankin Score 0 to 1
Time frame
90 days2
Proportion of patients with modified Rankin Score 0 to 2
Proportion of patients with modified Rankin Score 0 to 2
Time frame
90 days3
Modified Rankin Score
Modified Rankin Score
Time frame
90 days4
Decrease in national institutes of health stroke scale (NIHSS)
Decrease in NIHSS scoring at 48 hours after the treatment
Time frame
48 hoursOther outcomes
1
Differences in serum factors levels and blood gas in diverse vessel region
Differences in serum factors levels and blood gas in diverse vessel region
Time frame
Hour 02
Changes in serum factors levels
changes in serum factors levels before and at different timepoints after recanalization
Time frame
30 minutes, 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hui-Sheng Chen
Lead sponsor
General Hospital of Shenyang Military Region
Sponsor institution
Source ClinicalTrials.gov