Local Ischemic Postconditioning in Acute Ischemic Stroke

NCT06526429 | Completed DMC

• 1 other identifier: RAPID-SAVEI-01-2024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Acute Ischemic Stroke; Mechanical Thrombectomy; Ischemic Postconditioning; Brain Edema; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  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)

  within 7 days

Other Outcomes (1)

• Incidence of mitigation on infarction growth

  72 hours after procedure

Study Arms (6)

Dose 15

EXPERIMENTAL

Dose 15 involved 5 cycles of blow block and restoration, each for15 seconds.

Procedure: rapid local ischemic postconditioning

Dose 60

EXPERIMENTAL

Dose 60 involved 4 cycles of blow block and restoration, each for 60 seconds.

Procedure: rapid local ischemic postconditioning

Dose 120

EXPERIMENTAL

Dose 120 involved 4 cycles of blow block and restoration, each for 120 seconds.

Procedure: rapid local ischemic postconditioning

Dose 180

EXPERIMENTAL

Dose 180 involved 4 cycles of blow block and restoration, each for 180 seconds.

Procedure: rapid local ischemic postconditioning

Dose 240

EXPERIMENTAL

Dose 240 involved 4 cycles of blow block and restoration, each for 240 seconds.

Procedure: rapid local ischemic postconditioning

Dose 300

EXPERIMENTAL

Dose 300 involved 4 cycles of blow block and restoration, each for 300 seconds.

Procedure: rapid local ischemic postconditioning

Interventions

rapid local ischemic postconditioning PROCEDURE

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.

Dose 120; Dose 15; Dose 180; Dose 240; Dose 300; Dose 60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• Shanghai East Hospital: collaborator
• RenJi Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• Fujian Medical University Union Hospital: collaborator

Study Sites (2)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, 200023, China

Location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Brain Edema

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yueqi Zhu, MD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: October 14, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 20, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)