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

Phase 2RecruitingNCT05789823

Capital Medical University160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Acute Ischemic Stroke

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Infarct volume at 24 hours

Infarct volume on MRI-DWI at 24 hours after randomization

Time frame: 24 hours after randomization

Secondary Outcomes

Progression of infarct volume between baseline and 24 hours

Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization

Time frame: Baseline and 24 hours after randomization

Progression of perfusion defect from baseline to 24 hours

The volume difference of Tmax \> 6 s from baseline to 24 hours after randomization

Time frame: Baseline and 24 hours after randomization

Progression of infarct volume between 2 hours and 24 hours

Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization

Time frame: 2 hours after randomization and 24 hours after randomization

Infarct volume at 5 days/at discharge

Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge

Time frame: 5 days after randomization or at discharge

The proportion of functional independence at 90 days

The modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

Time frame: 90 days after randomization

The proportion of favorable outcome at 90 days

The mRS score of 0-3 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

Time frame: 90 days after randomization

The distribution of mRS score at 90 days

The distribution of the mRS score at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

Time frame: 90 days after randomization

National Institute of Health Stroke Scale (NIHSS) score at 24 hours

NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

Time frame: 24 hours after randomization

The proportion of early neurological improvement

NIHSS 0-2 or ≥ 8 lower than baseline NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

Time frame: Baseline and 24 hours after randomization

National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge

NIHSS score at 5 days after randomization/at discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

Time frame: 5 days after randomization or at discharge

Recanalization rate at 24 hours

Recanalization rate at 24 hours after randomization (eTICI 2b-3)

Time frame: 24 hours after randomization

Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.

Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization

Time frame: 24 hours after randomization

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts