Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)

Capital Medical University20 enrolled

Overview

Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. 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. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke Reperfusion Injury

Interventions

Mechanical thrombectomy combined with ischemic post-conditioningPROCEDURE

Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four 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: * Age ≥ 18 years; * Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; * Previous mRS ≤ 2; * Baseline NIHSS ≥ 6; * Baseline ASPECTS ≥ 6; * With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery; * Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA; * Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: * Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; * Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; * Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; * \> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy; * Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy; * Patients with contraindications to MRI; * Other conditions that the investigator considered inappropriate for inclusion.

Locations (1)

Tianjin Huanhu Hospital

Tianjin, China

Outcomes

Primary Outcomes

Infarct volume

Infarct volume at 72 hours after procedure

Time frame: 72 hours after procedure

Secondary Outcomes

The progression of infarct volume

Difference of infarct volume between baseline and 72 hours after procedure

Time frame: Baseline and 72 hours after procedure

The proportion of functional independence at 90 days

The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; 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 procedure

The proportion of favorable outcome at 90 days

The mRS score of 0-3 at 90 days after procedure; 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 procedure

The distribution of the mRS score at 90 days

The distribution of the mRS score at 90 days after procedure; 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 procedure

National Institute of Health Stroke Scale (NIHSS) score

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

Time frame: 24 hours after procedure

The proportion of early neurological improvement

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

Data from ClinicalTrials.gov

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