Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy
- Conditions
- Acute Ischemic Stroke
- Interventions
- Procedure: Local ischemic post-conditioning
- Registration Number
- NCT05153655
- Lead Sponsor
- Capital Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ischemic post-conditioning group Local ischemic post-conditioning The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China