Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

NCT07598799 | Not Yet Recruiting DMC

• 1 other identifier: RAPID IMPROVE-01
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, single-blind, randomized controlled trial (Phase IIb/III seamless design) to evaluate the efficacy and safety of rapid local ischemic postconditioning (RL-IPostC) performed immediately after successful recanalization by endovascular thrombectomy in patients with acute ischemic stroke due to large vessel occlusion with large ischemic core. Eligible patients will be randomized in a 1:1:1 ratio in Phase IIb to either high-dose RL-IPostC, low-dose RL-IPostC, or control (no postconditioning). After dose selection, Phase III will continue with a 1:1 randomization between the selected dose and control. The primary endpoint for Phase IIb is the proportion of patients with midline shift \>3 mm at the level of the septum pellucidum on 24-72 hour imaging. The primary endpoint for Phase III is the proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 ± 7 days post-procedure. Secondary endpoints include mRS 0-2, mRS distribution, NIHSS change, quality of life (EQ-5D-5L), imaging outcomes (infarct volume change, net water uptake change, CSF/ICV ratio change), and safety outcomes (symptomatic intracranial hemorrhage, mortality). The total planned sample size is up to 448 patients across approximately 30 centers in China.

Conditions

Acute Ischemic Stroke

Keywords

Ischemic postconditioning; Endovascular thrombectomy; Neuroprotection; Ischemic reperfusion injury

Outcome Measures

Primary Outcomes (2)

• Phase IIb: proportion of subjects with midline shift ( >3mm)

  Midline shift was measured at the level of the translucent septum in the follow-up NCCT 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: Chief

Study Record Dates

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

Record last verified: 2026-05