Direct Ischemic Conditioning for Stroke Treatment

Direct Ischemic Conditioning for Endovascular Recanalization for Anterior Large Vessel Occlusion (DICER-aLVO): a Prospective, Randomized, Open Label, Blinded-end Point, Phase 2, Multi-centre Study

This study is testing a new method called Direct Ischemic Conditioning to see if it can help improve recovery for stroke patients who have had a blocked blood vessel treated.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shengyang, Liaoning)
• Trial ID: NCT06940128 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Direct Ischemic Conditioning (DIC) to improve outcomes in patients with acute ischemic stroke caused by large vessel occlusion who have undergone endovascular recanalization. The study aims to enhance cerebral perfusion and reduce the risk of poor prognosis following treatment. Participants will receive different protocols of DIC to assess its neuroprotective effects and overall efficacy in improving functional outcomes. The trial is designed to address the challenge of ineffective perfusion, which affects a significant number of stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with acute anterior artery occlusion who have undergone successful recanalization within 24 hours of symptom onset.

Not a fit: Patients with significant residual stenosis, intracranial hemorrhagic diseases, or chronic liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies on Remote Ischemic Conditioning have shown promising results in improving outcomes for ischemic stroke, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

-1. Over 18 years old; 2. The time from onset to randomization is less than 24 hours; 3. Patients with acute anterior artery occlusion and receiving successful recanalization (mTICI 2b-3) after endovascular treatment and with residual stenosis ≤ 50%; 4. Cerebral circulation time after successful recanalization: affected side ≤ healthy side; 5. PH2 hemorrhage was excluded by immediate postoperative CT examination; 6. Re-onset patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points; 7. Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

\- 1. Spherical enlargement of the lesion site twice or more; 2. Proximal residual stenosis \>50% for patients with tandem lesions; 3. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc.

4\. Chronic liver disease, liver and kidney insufficiency, elevated ALT or AST (greater than 2 times the upper limit of normal), elevated serum creatinine (greater than 1.5 times the upper limit of normal) or dependent on kidney dialysis; 5. Women who are pregnant, have a pregnancy plan or are breastfeeding; 6. Combined with serious other diseases, life expectancy \< 6 months; 7. Other conditions deemed inappropriate for participation in this study.

Where this trial is running

Shengyang, Liaoning

• General Hospital of Northern Theater Command — Shengyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Hui-Sheng Chen

Conditions Ischemic Stroke; Direct Ischemic Conditioning; stroke; Endovascular Recanalization