Acute Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy
Brief summary
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.
Interventions
PROCEDURELocal ischemic post-conditioning
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.
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years; * Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion; * Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography; * Written informed consent provided by the patients or their legal relatives.
Exclusion criteria
* Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia; * Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; * Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures; * \> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures; * Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization; * Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with major response | Immediately after intervention on the day of ischemic post-conditioning | 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. |
Countries
China
Outcome results
None listed