Acute Ischemic StrokeRAPID-SAVENCT06307743
Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke
A study testing rapid local ischemic postconditioning in people with Acute Ischemic Stroke and Mechanical Thrombectomy, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial summary
The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke, Mechanical Thrombectomy, Ischemic Postconditioning
- What is being tested?
- rapid local ischemic postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Presenting with symptoms consistent with acute ischemic stroke
- Pre-stroke mRS score 0-1
- Baseline NIHSS score≥6
- Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time)
- Occlusion of the intracranial internal carotid artery, or the middle cerebral artery(M1 or M2) confirmed by CTA or MRA, and is the culprit artery
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- Alberta Stroke Program Early CT Score (ASPECTS) (based on non-contrast CT) >5 on noncontrast computed tomography (NCCT) for stroke onset time less than 6 hours, infarct Core < 70 ml (defined as rCBF <30% on CT perfusion) and mismatch ratio > 1.2 (penumbra defined as Tmax >6 seconds volume) for stroke onset time between 6 and 24 hours.
- Embolism verified as the etiology of occluded artery and mTICI 2b or 3 regained after mechanical thrombectomy
- Informed consent signed
Who cannot join
- Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery
- Multiple vascular embolism on different pathways (not refers to the ipsilateral middle artery and anterior artery)
- Pre ischemic stroke or transient ischemic attack within past 3 months
- The expected survival time is less than 6 months, could not be followed at 90 days (such as patient with malignant tumor)
- Currently pregnant, mental disease, advanced hepatic and renal insufficiency, severe heart failure
- Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial
- Other circumstances that the investigator considers inappropriate for this trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Open Label, Blind Endpoint, Clinical Trial to Evaluate the Efficacy and Safety of Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke Patients Received Successful Thrombectomy Reperfusion
The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.
Read the detailed description
This will be an umbrella trial of testing the efficacy and safety of three postconditioning intervention doses. It will be a prospective, open-label, blinded endpoint, three-dose Bayesian Optimal Phase 2(BOP2) design trial with interim efficacy and safety monitoring. The maximum number of subjects for this trial is estimated as 135 patients. Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as mTICI score 2b or 3. Patients will receive 5 cycles of balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the restoration of antegrade blood flow. Three postconditioning intervention doses of 30s/30s, 60s/60s and 180s/180s were adopted for block and restore of blood blow. The primary outcome is a favorable binary outcome defined as no clinically meaningful brain swelling from baseline to 24 hours and no clinically meaningful infarction growth from baseline to 24 hours and no causally attributable serious adverse events (SAEs). It's a composite outcome of efficacy and safety outcome. Key secondary outcomes include efficacy outcome indicating no clinically meaningful brain swelling defined by cerebral spinal fluid (CSF) volume reduction≤5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth>10 mL from baseline to 24 hours or causally attributable SAEs. Other secondary outcomes include change of brain net water uptake, midline shift and functional outcome. For each intervention dose, we will perform the interim analyses following pre-defined optimized Bayesian rule for early stopping to make a go/no-go decision when the number of enrolled patients reaches 10, 20, 30. The optimal intervention dose will be determined according to the number of patients reach the primary endpoints in different groups.
- Being tested
- rapid local ischemic postconditioning
- Medical subject headings
- Ischemic Stroke, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid local ischemic postconditioningProcedure or surgery
Rapid local ischemic postconditioning (RL-IPostC) is performed immediately (within 5 minutes) after revascularization. A balloon guiding catheter (BGC) positioned on ipsilateral C1 segment of internal carotid artery is inflated and deflated for the temporary occlusion of the antegrade flow.
| Study group | Role | What they receive |
|---|---|---|
| RL-IPostC 30 | Other | The RL-IPostC 30 protocol involved 5 cycles of blow block and restoration, each for 30 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| RL-IPostC 60 | Other | The RL-IPostC 60 protocol involved 5 cycles of blow block and restoration, each for 60 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| RL-IPostC 180 | Other | The RL-IPostC 180 protocol involved 5 cycles of blow block and restoration, each for 180 seconds. Receives: Procedure: rapid local ischemic postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.
No clinically meaningful cerebral swelling defined as volume reduction of cerebrospinal fluid ≤ 5 mL from baseline. No significant increase in infarct volume from baseline defined as an increase in infarct volume of ≤ 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
Measured: 24 hours after procedure
Secondary outcomes (11)
Rate of participants without clinically meaningful cerebral swelling
No clinically meaningful brain swelling defined by CSF volume reduction≤5 mL from baseline to 24 hours.
Measured: 24 hours after procedure
Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events.
Significant increase in infarct volume from baseline defined as an increase in infarct volume of more than 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
Measured: 24 hours after procedure
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours from baseline
Measured: 72 hours after procedure
Change of net water uptake (∆NWU24) at 24 hours
Change of net water uptake (∆NWU24) at 24 hours from baseline
Measured: 24 hours after procedure
Change of net water uptake (∆NWU72) at 72 hours
Change of net water uptake (∆NWU72) at 72 hours from baseline
Measured: 72 hours after procedure
Midline shift at 24 hours
Distance of midline shift at 24 hours (in millimeters at the level of the septum pellucidum)
Measured: 24 hours after procedure
Midline shift at 72 hours
Distance of midline shift at 72 hours (in millimeters at the level of the septum pellucidum)
Measured: 72 hours after procedure
Change of NIHSS at 24 hours
Change of NIHSS at 24 hours from baseline
Measured: 24 hours after procedure
Early therapeutic response to treatment
Decrease in the NIHSS score of ≥8 from baseline or an NIHSS score of 0 to 2 at 24 hours)
Measured: 24 hours after procedure
Good outcome at 90 days
Proportion of mRS score of 0 to 2 at 90 days
Measured: 90 days after procedure
Excellent outcome at 90 days
Proportion of mRS score of 0 to 1 at 90 days
Measured: 90 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, Shanghai East Hospital, First People's Hospital of Hangzhou, RenJi Hospital
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yueqi Zhu, MD, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307743
- Sponsor's protocol ID
- RAPID-SAVE
- Acronym
- RAPID-SAVE
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Blind Endpoint, Clinical Trial to Evaluate the Efficacy and Safety of Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke Patients Received Successful Thrombectomy Reperfusion
- ClinicalTrials.gov ID
- NCT06307743
- Acronym / sponsor ID
- RAPID-SAVE / RAPID-SAVE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, Shanghai East Hospital, First People's Hospital of Hangzhou, RenJi Hospital
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 13 Mar 2024 (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.
The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.
Detailed description
This will be an umbrella trial of testing the efficacy and safety of three postconditioning intervention doses. It will be a prospective, open-label, blinded endpoint, three-dose Bayesian Optimal Phase 2(BOP2) design trial with interim efficacy and safety monitoring. The maximum number of subjects for this trial is estimated as 135 patients. Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as mTICI score 2b or 3. Patients will receive 5 cycles of balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the restoration of antegrade blood flow. Three postconditioning intervention doses of 30s/30s, 60s/60s and 180s/180s were adopted for block and restore of blood blow. The primary outcome is a favorable binary outcome defined as no clinically meaningful brain swelling from baseline to 24 hours and no clinically meaningful infarction growth from baseline to 24 hours and no causally attributable serious adverse events (SAEs). It's a composite outcome of efficacy and safety outcome. Key secondary outcomes include efficacy outcome indicating no clinically meaningful brain swelling defined by cerebral spinal fluid (CSF) volume reduction≤5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth>10 mL from baseline to 24 hours or causally attributable SAEs. Other secondary outcomes include change of brain net water uptake, midline shift and functional outcome. For each intervention dose, we will perform the interim analyses following pre-defined optimized Bayesian rule for early stopping to make a go/no-go decision when the number of enrolled patients reaches 10, 20, 30. The optimal intervention dose will be determined according to the number of patients reach the primary endpoints in different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RL-IPostC 30 | Other | Procedure: rapid local ischemic postconditioningThe RL-IPostC 30 protocol involved 5 cycles of blow block and restoration, each for 30 seconds. |
| RL-IPostC 60 | Other | Procedure: rapid local ischemic postconditioningThe RL-IPostC 60 protocol involved 5 cycles of blow block and restoration, each for 60 seconds. |
| RL-IPostC 180 | Other | Procedure: rapid local ischemic postconditioningThe RL-IPostC 180 protocol involved 5 cycles of blow block and restoration, each for 180 seconds. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old
- Presenting with symptoms consistent with acute ischemic stroke
- Pre-stroke mRS score 0-1
- Baseline NIHSS score≥6
- Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time)
Key exclusion criteria (7 listed)
- Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery
- Multiple vascular embolism on different pathways (not refers to the ipsilateral middle artery and anterior artery)
- Pre ischemic stroke or transient ischemic attack within past 3 months
- The expected survival time is less than 6 months, could not be followed at 90 days (such as patient with malignant tumor)
- Currently pregnant, mental disease, advanced hepatic and renal insufficiency, severe heart failure
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 |
|---|---|---|
| rapid local ischemic postconditioningRapid local ischemic postconditioning (RL-IPostC) is performed immediately (within 5 minutes) after revascularization. A balloon guiding catheter (BGC) positioned on ipsilateral C1 segment of internal carotid artery is inflated and deflated for the temporary occlusion of the antegrade flow. | Procedure or surgery | RL-IPostC 180, RL-IPostC 30, RL-IPostC 60 |
Primary outcome
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.
Time frame: 24 hours after procedure
No clinically meaningful cerebral swelling defined as volume reduction of cerebrospinal fluid ≤ 5 mL from baseline. No significant increase in infarct volume from baseline defined as an increase in infarct volume of ≤ 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
11 secondary outcomes
Rate of participants without clinically meaningful cerebral swelling
Time frame: 24 hours after procedure
Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events.
Time frame: 24 hours after procedure
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours
Time frame: 72 hours after procedure
Change of net water uptake (∆NWU24) at 24 hours
Time frame: 24 hours after procedure
Change of net water uptake (∆NWU72) at 72 hours
Time frame: 72 hours after procedure
Midline shift at 24 hours
Time frame: 24 hours after procedure
Midline shift at 72 hours
Time frame: 72 hours after procedure
Change of NIHSS at 24 hours
Time frame: 24 hours after procedure
Early therapeutic response to treatment
Time frame: 24 hours after procedure
Good outcome at 90 days
Time frame: 90 days after procedure
Excellent outcome at 90 days
Time frame: 90 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yueqi Zhu, MD principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing rapid local ischemic postconditioning in people with Acute Ischemic Stroke and Mechanical Thrombectomy, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueqi Zhu, MD (0086-21-64844183, zhuyueqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events. (time frame: 24 hours after procedure). 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 13 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.