Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

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

Interventions

PROCEDURE

High-dose RL-IPostC

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.

PROCEDURE

Low-dose RL-IPostC

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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  lead OTHER

Principal Investigators

• Yueqi Zhu, MD · Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-05-30

Completion

2029-05-30