NCT05789823

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Mechanical thrombectomy combined with ischemic post-conditioning	Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
PROCEDURE	Mechanical thrombectomy alone	Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2023-03-29
• Last updated: 2025-03-26

Locations

1 site across 1 country: China