Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Number of participants with major response
Major response is any of the following: * Vessel perforation or rupture; * Reocclusion of the culprit vessel after post-conditioning; * Vessel dissection; * Severe vasospasm; * Ischemic post-conditioning related thrombotic events; * Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.
Time frame: Immediately after intervention on the day of ischemic post-conditioning
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