Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

NCT05153655 | Completed DMC

• 1 other identifier: PROTECT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; ischemic postconditioning; endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• Number of participants with major response

  Major response is any of the following: * Vessel perforation or rupture; * Reocclusion of the culprit vessel after post-conditioning; * Vessel dissection; * Severe vasospasm; * Ischemic post-conditioning related thrombotic events; * Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.

  Immediately after intervention on the day of ischemic post-conditioning

Study Arms (1)

Ischemic post-conditioning group

EXPERIMENTAL

The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design.

Procedure: Local ischemic post-conditioning

Interventions

Local ischemic post-conditioning PROCEDURE

Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.

Ischemic post-conditioning group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
• Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
• Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

• Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
• Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
• Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
• \> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
• Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

Location

Related Publications (2)

• Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27.

  PMID: 37497674 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: November 29, 2021
• First Posted: December 10, 2021
• Study Start: December 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: August 15, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)