Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

Study Overview
=================
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.

Official Title
-----------------
Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Procedure: Local ischemic post-conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic post-conditioning group<br>The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design. | Procedure: Local ischemic post-conditioning<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after intervention on the day of ischemic post-conditioning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy