Ischemic StrokeNCT04664946
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)
A study testing Intra-arterial administration of neuroprotective agents in people with Ischemic Stroke and Neuroprotection, run by Hui-Sheng Chen at 1 site in China.
Trial summary
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Neuroprotection
- What is being tested?
- Intra-arterial administration of neuroprotective agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Major neurologic deficits: 6≤NIHSS≤20;
- 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);
- Premorbid mRS 0 or 1;
- Signed informed consent.
Who cannot join
- Modified Rankin Score >2 caused by a history of prior stroke;
- Patients who underwent intravenous thrombolysis or Endovascular treatment;
- 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);
- Unsuitable for this clinical studies assessed by researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
- Conditions
- Ischemic Stroke, Neuroprotection
- Being tested
- Intra-arterial administration of neuroprotective agents
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial administration of neuroprotective agentsDrug
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial administration of 3-n-butylphthalide | Experimental | Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min. Receives: Drug: Intra-arterial administration of neuroprotective agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of server adverse events
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
Measured: 48 hours
Secondary outcomes (9)
Proportion of patients with modified Rankin Score 0 to 1
Proportion of patients with modified Rankin Score 0 to 1
Measured: 90 days
Proportion of patients with modified Rankin Score 0 to 2
Proportion of patients with modified Rankin Score 0 to 2
Measured: 90 days
Modified Rankin Score
Modified Rankin Score
Measured: 90 days
Decrease in national institutes of health stroke scale (NIHSS)
Decrease in NIHSS scoring at 48 hours after the treatment
Measured: 48 hours
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Measured: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment
Measured: 48 hours
Changes in cerebral edema
Cerebral edema was determined by cerebral volume or midline shift
Measured: 48 hours
All causes of death within 48 hours after the treatment
All causes of death within 48 hours after the treatment
Measured: 48 hours
Differences in serum factors levels in different artery region
Differences in serum factors levels in different Bessel region before recanalization
Measured: 0 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2020
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui-Sheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664946
- Sponsor's protocol ID
- k（2020）31
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT04664946
- Acronym / sponsor ID
- k（2020）31
- Conditions
- Ischemic Stroke, Neuroprotection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hui-Sheng ChenUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial administration of 3-n-butylphthalide | Experimental | Drug: Intra-arterial administration of neuroprotective agentsIntra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Major neurologic deficits: 6≤NIHSS≤20;
- 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);
- Premorbid mRS 0 or 1;
- Signed informed consent.
Key exclusion criteria (6 listed)
- Modified Rankin Score >2 caused by a history of prior stroke;
- Patients who underwent intravenous thrombolysis or Endovascular treatment;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial administration of neuroprotective agentsIntra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min. | Drug | Intra-arterial administration of 3-n-butylphthalide |
Primary outcome
Proportion of server adverse events
Time frame: 48 hours
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
9 secondary outcomes
Proportion of patients with modified Rankin Score 0 to 1
Time frame: 90 days
Proportion of patients with modified Rankin Score 0 to 2
Time frame: 90 days
Modified Rankin Score
Time frame: 90 days
Decrease in national institutes of health stroke scale (NIHSS)
Time frame: 48 hours
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Time frame: 48 hours
Changes in cerebral edema
Time frame: 48 hours
All causes of death within 48 hours after the treatment
Time frame: 48 hours
Differences in serum factors levels in different artery region
Time frame: 0 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-arterial administration of neuroprotective agents in people with Ischemic Stroke and Neuroprotection, run by Hui-Sheng Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Sheng T Chen, Ph.D. (+8613352452086, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of server adverse events (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.