Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

NCT07598799 | Not Yet Recruiting DMC

• 1 other identifier: RAPID IMPROVE
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main goal of this study is to find out if a new, quick "brain rescue" procedure can help people recover better from a severe stroke caused by a large vessel occlusion. When someone has this type of stroke, doctors often perform a procedure called an endovascular thrombectomy (EVT). In EVT, they thread a thin tube through a blood vessel up to the brain to remove the clot and restore blood flow. This is a highly effective treatment. However, for some patients, suddenly restoring blood flow can cause additional, unexpected injury to the brain. This is called "reperfusion injury." This study tests a technique called rapid local ischemic postconditioning (RL-IPostC) that might prevent this extra damage. It's a very simple additional step performed immediately after the clot is successfully removed. The doctor would briefly inflate and deflate a tiny balloon inside the proximal brain artery after recanalization, creating very short, controlled "pauses" in blood flow. This is believed to give brain cells a gentler "wake-up" call, helping them tolerate the return of oxygen-rich blood. The study will test two different "doses" of this procedure (meaning different numbers of inflation/deflation cycles) against the standard care (no additional procedure). Phase IIb (the first part): Which dose of RL-IPostC (high or low) is more promising for reducing early brain swelling (measured by whether the brain's midline has shifted less than 3 mm on a 24-hour scan)? Phase III (the main part): Using the best dose from Phase IIb, does RL-IPostC improve a patient's functional recovery three months later, specifically enabling them to walk and manage daily activities without help? A total of 288 participants who have had a large-vessel occlusion stroke and successful clot removal will be enrolled. If early results look promising but not quite conclusive, the study can increase the total number of participants up to 448 to get a clearer answer. If successful, this study could identify a simple, low-cost add-on procedure to a standard stroke treatment that improves long-term recovery and quality of life for thousands of stroke patients. It's a potential new tool to protect the brain after blood flow is restored. This is a carefully designed study testing a gentle "on/off" blood flow technique right after clot removal, to see if it can reduce brain injury and help people walk and live more independently after a severe stroke.

Conditions

Acute Ischemic Stroke

Keywords

Ischemic postconditioning; Endovascular thrombectomy; Neuroprotection; Ischemic reperfusion injury

Outcome Measures

Primary Outcomes (2)

• Phase IIb: proportion of subjects without midline shift ( >3mm)

  Midline shift was measured at the level of the translucent septum in the follow-up NCCT or MRI at 24 hours.

  24 ± 6 hours after randomization

• Phase III: Proportion of subjects with mRS 0-3 at 90 days.

  The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death

  90 ± 7 days post-procedure

Secondary Outcomes (8)

• Proportion of subjects with good outcome (mRS 0-2) at 90 days

  90 ± 7 days post-procedure

• Distribution of mRS at 90 days

  90 ± 7 days post-procedure

• Proportion of subjects with mRS 0-3 at 1 year

  1 year ± 15 days post-procedure.

• Proportion of subjects with mRS 0-2 at 1 year

  1 year ± 15 days post-procedure.

• Distribution of mRS at 1 year.

  1 year ± 15 days post-procedure.

Other Outcomes (6)

• Infarct volume at 24-72 hours post-randomization

  24-72 hours post-randomization

• Ratio of increase in infarct volume at 24-72 hours post-randomization compared to baseline infarct volume

  24-72 hours post-randomization

• Change in net water uptake between 24-72 hours post-randomization and pre-procedure

  24-72 hours post-randomization

Study Arms (3)

High-dose RL-IPostC

EXPERIMENTAL

Postconditioning intervention with 2 minutes of inflation / 2 minutes of deflation, for 4 cycles.

Procedure: High-dose RL-IPostC

Low-dose RL-IPostC

EXPERIMENTAL

Postconditioning intervention with 15 seconds of inflation / 15 seconds of deflation, for 5 cycles.

Procedure: Low-dose RL-IPostC

Control

NO INTERVENTION

No postconditioning intervention after successful thrombectomy.

Interventions

High-dose RL-IPostC PROCEDURE

For acute anterior circulation with large core ischemic stroke patients who achieve successful vessel recanalization (mTICI 2b/3) after thrombectomy, within 5 minutes, the balloon guide catheter (BGC) is positioned in the straight segment of the ipsilateral internal carotid artery at the C1-C2 level, avoiding the carotid sinus. Repetitive balloon inflations (2 minutes) to block blood flow followed by deflations (2 minutes) to restore blood flow (for 4 cycles) are performed. After the first BGC inflation, confirmation of antegrade flow blockade in the internal carotid artery is required. At the end of the cycle, angiography is performed to confirm vessel patency.

High-dose RL-IPostC

Low-dose RL-IPostC PROCEDURE

For acute anterior circulation with large core ischemic stroke patients who achieve successful vessel recanalization (mTICI 2b/3) after thrombectomy, within 5 minutes, the balloon guide catheter (BGC) is positioned in the straight segment of the ipsilateral internal carotid artery at the C1-C2 level, avoiding the carotid sinus. Repetitive balloon inflations (15 seconds) to block blood flow followed by deflations (15 seconds) to restore blood flow (for 5 cycles) are performed. After the first BGC inflation, confirmation of antegrade flow blockade in the internal carotid artery is required. At the end of the cycle, angiography is performed to confirm vessel patency.

Low-dose RL-IPostC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years
• Diagnosis of acute ischemic stroke
• Pre-stroke mRS 0-1
• Baseline NIHSS score ≥ 6
• Time from symptom onset to start of endovascular procedure (puncture) \< 24 hours; onset time defined as "last known well" time
• Imaging criteria: ASPECTS 3-5 on CT, or ASPECTS \> 5 with acute ischemic core volume (defined as rCBF \< 30% or ADC \< 620) ≥ 50 mL
• Occlusion of the intracranial segment of the internal carotid artery or the middle cerebral artery (M1/M2), confirmed as the symptomatic culprit vessel
• After thrombectomy, the culprit vessel is considered to be occluded by an embolus, and successful recanalization (mTICI 2b/3, i.e., ≥ 50% perfusion) is achieved
• Written informed consent signed by the patient or a legal representative

You may not qualify if:

• Presence of stenosis (≥ 50%) in the ipsilateral middle cerebral artery, internal carotid artery, or common carotid artery proximal to the occlusion site
• Multiple emboli across different circulations (simultaneous anterior and posterior circulation emboli, or simultaneous left and right anterior circulation emboli)
• Evidence on CT of extensive cerebral edema, midline shift, significant mass effect, or signs of brain herniation
• Presence of a life-threatening disease with a prognosis \< 6 months, making 3-month follow-up impossible
• Severe psychiatric disorder or heart failure
• Concurrent participation in another clinical drug or device study
• Any other condition that, in the investigator's judgment, makes the subject unsuitable for this study

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

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

Central Study Contacts

Yining Tao, MD

CONTACT

0086-021-64844183; yiningtao1001@163.com

Jiangshan Deng, MD

CONTACT

0086-021-64507181; johnson120@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Radiology Department

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06