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

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 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.

Control group

Mechanical thrombectomy alone

Group Type SHAM_COMPARATOR

Mechanical thrombectomy alone

Intervention Type PROCEDURE

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

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 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.

Intervention Type PROCEDURE

Mechanical thrombectomy alone

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No