Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Capital Medical University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants with major response
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Ji Xunming,MD,PhD
Professor
Capital Medical University
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.
Outcomes
Primary Outcomes
Number of participants with major response
Time Frame: 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.