Acute Ischemic StrokeRAPID-SAVEINCT06526429
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 at 2 sites in China.
Trial summary
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 25 participants
- Where
- 2 sitesChina
- Study dates
- 14 Oct 2024to 20 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Presenting with symptoms and signs consistent with acute anterior circulation ischemic stroke
- Pre-stroke modified Rankin Score 0-1
- Baseline National Institute of Health Stroke Scale (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 (MCA) (M1 or M2) and is the culprit artery
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- Ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by CT perfusion imaging
- Embolism verified as the etiology of occluded artery and modified Thrombolysis in Cerebral Infarction Score (mTICI) 2b or 3 achieved after mechanical thrombectomy.
- Time from CT perfusion to reperfusion < 2 hours
- 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
- Evidence of internal carotid artery lesion that precludes the access and application of balloon guide catheter
- Multiple vascular embolism on different pathways (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
- Pre ischemic stroke 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
2 sites in 1 country.
China2 sites
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, 200023
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, 200233
About this study
Official title: RAPID Local Ischemic Postconditioning in Acute Ischemic Stroke pAtients receiVEd Successful Thrombectomy Reperfusion
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. In this trial, investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter (BGC) 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. The optimal postconditioning intervention dose will be determined for further investigation.
Read the detailed description
This will be an Bayesian Optimal Interval Phase I/II (BOIN12) trial design to determine the safety and optimal dose of ischemic postconditioning intervention. The BOIN12 design makes the decision of dose escalation and de-escalation by simultaneously taking account of toxicity and efficacy and it quantifies the desirability of a dose in terms of toxicity-efficacy trade off. Under BOIN12, patients are adaptively assigned to the most desirable dose with the optimal toxicity-efficacy trade-off.
Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI) score 2b or 3. Participants will receive balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the antegrade blood flow.
Six postconditioning intervention doses were adopted for blocking and restoration of blood blow. This study will include 6 doses with the start dose set at dose 180. Dose 15: 15s/15s, 5 cycles; Dose 60: 60s/60s, 4 cycles; Dose 120: 120s/120s, 4 cycles; Dose 180: 180s/180s, 4 cycles; Dose 240: 240s/240s, 4 cycles; Dose 300: 300s/300s, 4 cycles. In this trial, a maximum number of 60 participants will be enrolled with a cohort size of 5 and cohort number of 12. The maximum sample size of each dose is set at 20.
The safety outcome within 7 days (dose limiting toxicity, DLT) including any one of: 1) malignant middle cerebral artery (MCA) infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation; 2) procedure related serious adverse events(SAEs); 3) other causally attributable SAEs. Efficacy outcome was patients without clinically meaningful infarction growth at 72 hours (defined as infarction growth<10 mL from baseline to 72 hours).
- Conditions
- Acute Ischemic Stroke, Mechanical Thrombectomy, Ischemic Postconditioning, Brain Edema, Neuroprotection
- 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 |
|---|---|---|
| Dose 15 | Experimental | Dose 15 involved 5 cycles of blow block and restoration, each for15 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| Dose 60 | Experimental | Dose 60 involved 4 cycles of blow block and restoration, each for 60 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| Dose 120 | Experimental | Dose 120 involved 4 cycles of blow block and restoration, each for 120 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| Dose 180 | Experimental | Dose 180 involved 4 cycles of blow block and restoration, each for 180 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| Dose 240 | Experimental | Dose 240 involved 4 cycles of blow block and restoration, each for 240 seconds. Receives: Procedure: rapid local ischemic postconditioning |
| Dose 300 | Experimental | Dose 300 involved 4 cycles of blow block and restoration, each for 300 seconds. Receives: Procedure: rapid local ischemic postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events including any one of below:
- Malignant middle cerebral artery infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation.
- Complications related to ischemic postcondition intervention that require treatment including distal vascular embolism, local arterial dissection, and local vascular spasm at the intervention site of the internal carotid artery.
- Other causally attributable serious adverse events (SAEs)
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start14 Oct 2024
- Primary completion4 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 25 participants (actual)
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, RenJi Hospital, First People's Hospital of Hangzhou, Fujian Medical University Union 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
- NCT06526429
- Sponsor's protocol ID
- RAPID-SAVEI-01-2024
- Acronym
- RAPID-SAVEI
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng J, Yi T, Tao Y, He G, Wei L, Lu H, Zhou Q, Shi F, Yin C, Li G, Wan J, Lin L, Parsons M, Chen W, Zhu Y. Safety of Rapid Local Ischemic Postconditioning After Thrombectomy in Acute Stroke: A Dose-Finding Trial (RAPID SAVE). Stroke. 2026 Jul;57(7):1950-1959. doi: 10.1161/STROKEAHA.126.055708. Epub 2026 May 11.
PubMed 42109123
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID Local Ischemic Postconditioning in Acute Ischemic Stroke pAtients receiVEd Successful Thrombectomy Reperfusion
- ClinicalTrials.gov ID
- NCT06526429
- Acronym / sponsor ID
- RAPID-SAVEI / RAPID-SAVEI-01-2024
- Conditions
- Acute Ischemic Stroke, Mechanical Thrombectomy, Ischemic Postconditioning, Brain Edema, Neuroprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, Shanghai East Hospital, RenJi Hospital, First People's Hospital of Hangzhou, Fujian Medical University Union Hospital
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 29 Jul 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.
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. In this trial, investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter (BGC) 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. The optimal postconditioning intervention dose will be determined for further investigation.
Detailed description
This will be an Bayesian Optimal Interval Phase I/II (BOIN12) trial design to determine the safety and optimal dose of ischemic postconditioning intervention. The BOIN12 design makes the decision of dose escalation and de-escalation by simultaneously taking account of toxicity and efficacy and it quantifies the desirability of a dose in terms of toxicity-efficacy trade off. Under BOIN12, patients are adaptively assigned to the most desirable dose with the optimal toxicity-efficacy trade-off.
Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI) score 2b or 3. Participants will receive balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the antegrade blood flow.
Six postconditioning intervention doses were adopted for blocking and restoration of blood blow. This study will include 6 doses with the start dose set at dose 180. Dose 15: 15s/15s, 5 cycles; Dose 60: 60s/60s, 4 cycles; Dose 120: 120s/120s, 4 cycles; Dose 180: 180s/180s, 4 cycles; Dose 240: 240s/240s, 4 cycles; Dose 300: 300s/300s, 4 cycles. In this trial, a maximum number of 60 participants will be enrolled with a cohort size of 5 and cohort number of 12. The maximum sample size of each dose is set at 20.
The safety outcome within 7 days (dose limiting toxicity, DLT) including any one of: 1) malignant middle cerebral artery (MCA) infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation; 2) procedure related serious adverse events(SAEs); 3) other causally attributable SAEs. Efficacy outcome was patients without clinically meaningful infarction growth at 72 hours (defined as infarction growth<10 mL from baseline to 72 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose 15 | Experimental | Procedure: rapid local ischemic postconditioningDose 15 involved 5 cycles of blow block and restoration, each for15 seconds. |
| Dose 60 | Experimental | Procedure: rapid local ischemic postconditioningDose 60 involved 4 cycles of blow block and restoration, each for 60 seconds. |
| Dose 120 | Experimental | Procedure: rapid local ischemic postconditioningDose 120 involved 4 cycles of blow block and restoration, each for 120 seconds. |
| Dose 180 | Experimental | Procedure: rapid local ischemic postconditioningDose 180 involved 4 cycles of blow block and restoration, each for 180 seconds. |
| Dose 240 | Experimental | Procedure: rapid local ischemic postconditioningDose 240 involved 4 cycles of blow block and restoration, each for 240 seconds. |
| Dose 300 | Experimental | Procedure: rapid local ischemic postconditioningDose 300 involved 4 cycles of blow block and restoration, each for 300 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- Presenting with symptoms and signs consistent with acute anterior circulation ischemic stroke
- Pre-stroke modified Rankin Score 0-1
- Baseline National Institute of Health Stroke Scale (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 (8 listed)
- Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery
- Evidence of internal carotid artery lesion that precludes the access and application of balloon guide catheter
- Multiple vascular embolism on different pathways (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
- Pre ischemic stroke 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)
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 | Dose 120, Dose 15, Dose 180, Dose 240, Dose 300, Dose 60 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: within 7 days
Treatment-Emergent Adverse Events including any one of below: 1. Malignant middle cerebral artery infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation. 2. Complications related to ischemic postcondition intervention that require treatment including distal vascular embolism, local arterial dissection, and local vascular spasm at the intervention site of the internal carotid artery. 3. Other causally attributable serious adverse events (SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 42109123Deng J, Yi T, Tao Y, He G, Wei L, Lu H, Zhou Q, Shi F, Yin C, Li G, Wan J, Lin L, Parsons M, Chen W, Zhu Y. Safety of Rapid Local Ischemic Postconditioning After Thrombectomy in Acute Stroke: A Dose-Finding Trial (RAPID SAVE). Stroke. 2026 Jul;57(7):1950-1959. doi: 10.1161/STROKEAHA.126.055708. Epub 2026 May 11.
- 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
2 sites in 1 country: see every site and its status.
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 at 2 sites 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526429, which also lists 1 linked publication.
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 28 Nov 2025; AzTrials last refreshed its copy on 28 Oct 2026.