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Completed

NCT Number: NCT05909982

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

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.

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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 Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Huanhu Hospital

Tianjin, 300350, China

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;
  • 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.

Exclusion criteria

  • 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;
  • 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 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.

Primary outcomes

  1. Infarct volume

    Time frame: 72 hours after procedure

    Infarct volume at 72 hours after procedure

Secondary outcomes

  1. The progression of infarct volume

    Time frame: Baseline and 72 hours after procedure

    Difference of infarct volume between baseline and 72 hours after procedure

  2. The proportion of functional independence at 90 days

    Time frame: 90 days after procedure

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

  3. The proportion of favorable outcome at 90 days

    Time frame: 90 days after procedure

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

  4. The distribution of the mRS score at 90 days

    Time frame: 90 days after procedure

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

  5. National Institute of Health Stroke Scale (NIHSS) score

    Time frame: 24 hours after procedure

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

  6. The proportion of early neurological improvement

    Time frame: 24 hours after procedure

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

  7. NIHSS score at 7 days after procedure/discharge

    Time frame: 7 days after procedure/discharge

    NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits

  8. Recanalization rate

    Time frame: 24 hours after procedure

    Recanalization rate at 24 hours after procedure (mTICI ≥2b)

  9. Hemodynamic assessment

    Time frame: Within 24 hours after procedure

    Hemodynamic assessment within 24 hours after procedure

Other outcomes

  1. Safety outcome (mortality at 90 days)

    Time frame: 90 days after procedure

    90-day mortality

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

    Time frame: Within 24 hours after procedure

    The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure

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

    Time frame: Within 24 hours after procedure

    The proportion of intracranial hemorrhage within 24 hours after procedure

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

    Time frame: Within 24 hours after procedure

    The proportion of malignant brain edema within 24 hours after procedure

  5. Procedure-related complications

    Time frame: During the procedure

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

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Acronym: PROTECT

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Mar 18, 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.

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