NCT05909982

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)

Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. 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. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Conditions

• Acute Ischemic Stroke
• Reperfusion Injury

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 by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-10-15
• Completion: 2024-01-28
• First posted: 2023-06-18
• Last updated: 2025-03-18

Locations

1 site across 1 country: China