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

Capital Medical University

Status and phase: Enrolling; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Mechanical thrombectomy combined with ischemic post-conditioning; Procedure: Mechanical thrombectomy alone

Study type: Interventional

Funder types: Other

Identifiers

NCT05789823

PROTECT-2

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Ischemic post-conditioning group

Experimental group

Description:

Mechanical thrombectomy combined with ischemic post-conditioning

Treatment:

Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

Control group

Sham Comparator group

Description:

Mechanical thrombectomy alone

Treatment:

Procedure: Mechanical thrombectomy alone