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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-01-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Ischemic Stroke Reperfusion Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ischemic post-conditioning group

Mechanical thrombectomy combined with ischemic post-conditioning

Group Type EXPERIMENTAL

Mechanical thrombectomy combined with ischemic post-conditioning

Intervention Type PROCEDURE

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.

Interventions

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Mechanical thrombectomy combined with ischemic post-conditioning

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No