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

Phase 2

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Mechanical thrombectomy alone; Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

• Registration Number: NCT05789823
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-11-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Mechanical thrombectomy alone	Mechanical thrombectomy alone
Ischemic post-conditioning group	Mechanical thrombectomy combined with ischemic post-conditioning	Mechanical thrombectomy combined with ischemic post-conditioning

Primary Outcome Measures

Name	Time	Method
Infarct volume at 24 hours	24 hours after randomization	Infarct volume on MRI-DWI at 24 hours after randomization

Secondary Outcome Measures

Name	Time	Method
Progression of infarct volume between baseline and 24 hours	Baseline and 24 hours after randomization	Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization
Progression of perfusion defect from baseline to 24 hours	Baseline and 24 hours after randomization	The volume difference of Tmax \> 6 s from baseline to 24 hours after randomization
Progression of infarct volume between 2 hours and 24 hours	2 hours after randomization and 24 hours after randomization	Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization
Infarct volume at 5 days/at discharge	5 days after randomization or at discharge	Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge
The proportion of functional independence at 90 days	90 days after randomization	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)
The proportion of favorable outcome at 90 days	90 days after randomization	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)
The distribution of mRS score at 90 days	90 days after randomization	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)
National Institute of Health Stroke Scale (NIHSS) score at 24 hours	24 hours after randomization	NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
The proportion of early neurological improvement	Baseline and 24 hours after randomization	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
National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge	5 days after randomization or 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
Recanalization rate at 24 hours	24 hours after randomization	Recanalization rate at 24 hours after randomization (eTICI 2b-3)
Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.	24 hours after randomization	Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization

Trial Locations

Locations (1)

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China