NCT06967025

Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy

Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy: Mechanistic Exploration Through a Randomized Controlled Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate whether on-site ischemic postconditioning (IPostC) improves outcomes in acute stroke patients receiving endovascular thrombectomy (EVT) and explore its mechanisms. The investigators aim to answer: (1) Is on-site IPostC effective compared to EVT alone? (2) What molecular markers and cellular pathways does on-site IPostC influence? Participants will be randomized to EVT alone or EVT+IPostC (4 cycles of 2-minute balloon occlusion/reperfusion). The investigators will assess infarct size, functional outcomes, biomarkers (e.g., multi-omics, ELISA, and clinical laboratory parameters), and safety (e.g., mortality, procedure-related complications).

Detailed description

This clinical trial is a single-center, prospective, blind endpoint, randomized -controlled trial. Randomization will be in a 1:1 ratio, Intervention Arm (EVT + on-site IPostC) or Control Arm (EVT alone) in up to a total of 60 patients (30 subjects in each arm). On-site IPostC will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus, consisting of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion).

Conditions

• Stroke Acute
• Cytoprotection
• Ischemic Conditioning

Interventions

Type	Name	Description
PROCEDURE	Ischemic Postconditioning	Ischemic Postconditioning will consist of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion), and will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus.
PROCEDURE	Endovascular Thrombectomy	Thrombectomy alone.

Timeline

• Start date: 2024-09-12
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2025-05-13
• Last updated: 2025-12-15

Locations

1 site across 1 country: China