RECRUITINGPhase 2INTERVENTIONAL

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy

About This Trial

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years; 2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; 3. Previous mRS ≤ 2; 4. Baseline NIHSS ≥ 6; 5. Baseline ASPECTS ≥ 6; 6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion; 7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3); 8. Written willing to sign a consent form provided by the patients or their legal relatives. Who Should NOT Join This Trial: 1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; 2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; 3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus; 4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; 5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; 6. Patients with contraindications to MRI; 7. Other conditions that the investigator considered inappropriate for inclusion. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥ 18 years; 2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; 3. Previous mRS ≤ 2; 4. Baseline NIHSS ≥ 6; 5. Baseline ASPECTS ≥ 6; 6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion; 7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3); 8. Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: 1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; 2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; 3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus; 4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; 5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; 6. Patients with contraindications to MRI; 7. Other conditions that the investigator considered inappropriate for inclusion.

Treatments Being Tested

PROCEDURE

Mechanical thrombectomy combined with ischemic post-conditioning

Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

PROCEDURE

Mechanical thrombectomy alone

Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Locations (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China