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Completed

NCT Number: NCT05153655

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with major response

    Time frame: Immediately after intervention on the day of ischemic post-conditioning

    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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Acronym: PROTECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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