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

NCT05909982 | Completed Phase 1 DMC

• 1 other identifier: PROTECT-1b
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• Infarct volume

  Infarct volume at 72 hours after procedure

  72 hours after procedure

Secondary Outcomes (9)

• The progression of infarct volume

  Baseline and 72 hours after procedure

• The proportion of functional independence at 90 days

  90 days after procedure

• The proportion of favorable outcome at 90 days

  90 days after procedure

• The distribution of the mRS score at 90 days

  90 days after procedure

• National Institute of Health Stroke Scale (NIHSS) score

  24 hours after procedure

Other Outcomes (5)

• Safety outcome (mortality at 90 days)

  90 days after procedure

• Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)

  Within 24 hours after procedure

• Safety outcome (the proportion of intracranial hemorrhage within 24 hours)

  Within 24 hours after procedure

Study Arms (1)

Ischemic post-conditioning group

EXPERIMENTAL

Mechanical thrombectomy combined with ischemic post-conditioning

Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

Interventions

Mechanical thrombectomy combined with ischemic post-conditioning 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.

Ischemic post-conditioning group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, 300350, China

Location

Related Publications (2)

• Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.

  PMID: 36523440 BACKGROUND

• Jiang X, Wu L, Liu S, Xu Y, Zhang B, Wang S, Luo L, Zhao W, Yao Y, Cao C, Zhao H, Ji X, Wei M. In situ ischemic postconditioning for acute ischemic stroke: preliminary exploratory study. J Neurointerv Surg. 2025 Aug 31:jnis-2025-024031. doi: 10.1136/jnis-2025-024031. Online ahead of print.

  PMID: 40889891 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Reperfusion Injury

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: April 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: January 28, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)