NCT06940128

Direct Ischemic Conditioning for Endovascular Recanalization for Anterior Large Vessel Occlusion (DICER-aLVO)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute ischemic stroke (AIS) is the most common type of stroke, with high incidence rate and mortality. Endovascular therapy is currently the most effective treatment for AIS with large vessel occlusion, but only about 50% of patients achieve good outcome after endovascular therapy, while 50% of patients have poor prognosis, commonly referred to as ineffective perfusion. Therefore, how to improve ineffective perfusion is currently a hot topic. Numerous studies have shown that Remote Ischemic Therapy (RIC) has a protective effect on ischemic stroke. Our recent RICAMIS study has demonstrated that RIC can significantly improve the functional prognosis of moderate acute ischemic stroke. Furthermore, direct ischemic conditioning has also showed neuroprotective effect. For example, in a rat model, within 2 minutes after reperfusion, using three cycles of 30 s reperfusion and 10 s occlusion for direct ischemic conditioning can effectively alleviate hyperperfusion and reduce cerebral infarction volume. Meanwhile, in previous clinical exploration studies, it was found that even induction by 5-minute ischemia and 5-minute reperfusion for up to 4 cycles is safe, feasible, and well tolerated for AIS patients receiving endovascular treatment. Immediate control of bilateral carotid artery blood flow after ischemia-reperfusion can significantly reduce cerebral infarction area and brain edema, and improve neurological function recovery in rats. Subsequent molecular mechanism studies have shown that direct ischemic conditioning can reduce the production of free radicals after cerebral ischemia-reperfusion, inhibit inflammatory reactions and cell apoptosis, downregulate the expression of signaling molecules mediating brain edema, promote Akt survival pathway, and improve the integrity of the blood-brain barrier, thereby exerting neuroprotective effects. Recent studies have also confirmed the safety and feasibility of direct ischemic conditioning for stroke patients achieving successful recanalization. More importantly, a recent cohort study has shown that direct ischemic conditioning can reduce infarct growth and brain edema after reperfusion in patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation, and improve prognosis after 90 days. Based on the above discussion, this trial aims to evaluate the effectiveness and safety of direct ischemic conditioning for patients with AIS who have undergone thrombectomy for occlusion of large blood vessels in the anterior circulation.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Direct Ischemic Conditioning A	Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 5 cycles of 30-s balloon inflations and 30-s deflations.
PROCEDURE	Direct Ischemic Conditioning B	Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 4 cycles of 60-s balloon inflations and 60-s deflations.
PROCEDURE	Direct Ischemic Conditioning C	Direct Ischemic Conditioning initiated within 5 minutes post-revascularization using either a balloon guiding catheter or a balloon catheter, positioned at the C1 segment of the ipsilateral internal carotid artery (ICA) to temporarily halt antegrade flow. The protocol comprised 3 cycles of 120-s balloon inflations and 120-s deflations.

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-01-01
• Completion: 2026-03-31
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: China