Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study

Area of Science:

• Neurology
• Interventional Neurology
• Stroke Medicine

Background:

• Ischemic post-conditioning shows neuroprotection in experimental stroke models by reducing ischemia-reperfusion injury.
• The efficacy of ischemic post-conditioning is duration-dependent.
• Clinical application of ischemic post-conditioning in acute ischemic stroke is unexplored.

Purpose of the Study:

• To determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke receiving mechanical thrombectomy.
• To establish the maximum tolerable duration of ischemic post-conditioning in this patient population.

Main Methods:

• A 3+3 dose-escalation design with duration escalation (0-5 min) for ischemic post-conditioning.
• Ischemic post-conditioning involves balloon inflations proximal to the occlusion after mechanical thrombectomy.
• Pre-defined stopping rules identify major adverse events to ensure patient safety.

Main Results:

• This section is not applicable as the study is evaluating safety and tolerability.

Conclusions:

• This clinical trial is the first to assess the safety and tolerability of ischemic post-conditioning in acute ischemic stroke patients undergoing mechanical thrombectomy.
• The maximum tolerable duration will inform future efficacy studies of ischemic post-conditioning for stroke treatment.