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

Phase 1

Completed

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

• Registration Number: NCT05909982
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Primary Completion: 2023-10-15
• Study Completion: 2024-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	72 hours after procedure	Infarct volume at 72 hours after procedure

Secondary Outcome Measures

Name	Time	Method
The progression of infarct volume	Baseline and 72 hours after procedure	Difference of infarct volume between baseline and 72 hours after procedure
The proportion of functional independence at 90 days	90 days after procedure	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)
The distribution of the mRS score at 90 days	90 days after procedure	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)
The proportion of early neurological improvement	24 hours after procedure	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
Recanalization rate	24 hours after procedure	Recanalization rate at 24 hours after procedure (mTICI ≥2b)
National Institute of Health Stroke Scale (NIHSS) score	24 hours after procedure	NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
The proportion of favorable outcome at 90 days	90 days after procedure	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)
NIHSS score at 7 days after procedure/discharge	7 days after procedure/discharge	NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Hemodynamic assessment	Within 24 hours after procedure	Hemodynamic assessment within 24 hours after procedure

Trial Locations

Locations (1)

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, China