Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05789823

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

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

Recruiting

Interested in participating?

Request Info

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

Location status: Recruiting

Location contact

Ming We, MD

CONTACT

[email protected]

+86-13502182903

Who can participate

Healthy volunteers accepted: No

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

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;
  • Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
  • Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
  • 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;
  • Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
  • Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
  • > 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
  • Patients with contraindications to MRI;
  • Other conditions that the investigator considered inappropriate for inclusion.

Treatment and study plan

Mechanical thrombectomy combined with ischemic post-conditioning

Procedure

Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

Mechanical thrombectomy alone

Procedure

Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Primary outcomes

  1. Infarct volume at 24 hours

    Time frame: 24 hours after randomization

    Infarct volume on MRI-DWI at 24 hours after randomization

Secondary outcomes

  1. Progression of infarct volume between baseline and 24 hours

    Time frame: Baseline and 24 hours after randomization

    Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization

  2. Progression of perfusion defect from baseline to 24 hours

    Time frame: Baseline and 24 hours after randomization

    The volume difference of Tmax > 6 s from baseline to 24 hours after randomization

  3. Progression of infarct volume between 2 hours and 24 hours

    Time frame: 2 hours after randomization and 24 hours after randomization

    Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization

  4. Infarct volume at 5 days/at discharge

    Time frame: 5 days after randomization or at discharge

    Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge

  5. The proportion of functional independence at 90 days

    Time frame: 90 days after randomization

    The modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

  6. The proportion of favorable outcome at 90 days

    Time frame: 90 days after randomization

    The mRS score of 0-3 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

  7. The distribution of mRS score at 90 days

    Time frame: 90 days after randomization

    The distribution of the mRS score at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

  8. National Institute of Health Stroke Scale (NIHSS) score at 24 hours

    Time frame: 24 hours after randomization

    NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

  9. The proportion of early neurological improvement

    Time frame: Baseline and 24 hours after randomization

    NIHSS 0-2 or ≥ 8 lower than baseline NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

  10. National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge

    Time frame: 5 days after randomization or at discharge

    NIHSS score at 5 days after randomization/at discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

  11. Recanalization rate at 24 hours

    Time frame: 24 hours after randomization

    Recanalization rate at 24 hours after randomization (eTICI 2b-3)

  12. Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.

    Time frame: 24 hours after randomization

    Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization

Other outcomes

  1. Safety outcome (mortality at 90 days)

    Time frame: 90 days after randomization

    90-day mortality

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

    Time frame: Within 24 hours after randomization

    The proportion of symptomatic intracranial hemorrhage within 24 hours after randomization

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

    Time frame: Within 24 hours after randomization

    The proportion of intracranial hemorrhage within 24 hours after randomization

  4. Safety outcome (the proportion of malignant brain edema within 24 hours)

    Time frame: Within 24 hours after randomization

    The proportion of malignant brain edema within 24 hours after randomization

  5. Procedure-related complications

    Time frame: During the procedure

    Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning

Study contacts

Contact information is provided by the study sponsor or research team.

Xunming Ji, MD

CONTACT

[email protected]

010-83198952

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2023
Registry last updated
Mar 26, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.