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NCT Number: NCT05024292

Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, Fujian, China

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About this study

For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
  • Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
  • Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
  • Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
  • The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt

Exclusion criteria

  • Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
  • Patients underwent rescue angioplasty or stenting after thrombectomy

Treatment and study plan

rapid local ischemic postconditioning (RL-IPostC)

Procedure

with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation

Primary outcomes

  1. functional independence

    Time frame: 3 month

    mRS 0-2

Secondary outcomes

  1. excellent functional independence

    Time frame: 3 month

    mRS 0-1

  2. early therapeutic response

    Time frame: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5

    defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1

  3. Mortality

    Time frame: 3 month

    Mortality of 3 month after stoke onset

  4. hemorrhagic transformation

    Time frame: 24 hours after treatment

    according to European Cooperative Acute Stroke Study II criteria

  5. Symptomatic intracerebral hemorrhage (sICH)

    Time frame: 24 hours after treatment

    an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification

  6. malignant infarction

    Time frame: 24 hours after treatment

    defined as infarct lesions with significant space-occupying mass effect with over 1/2 affected middle cerebral artery territory with imaging signs of herniation and/or and clinical signs of herniation requiring decompressive hemicraniectomy and/or leading to death due to direct implications of stroke

Study contacts

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

Yueqi Zhu, PhD

CONTACT

[email protected]

+86-21-18930177565

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Collaborators

  • Zhangzhou Municipal Hospital of Fujian Province

Registry information

Official study title

Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy

Acronym: ORANGE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2021
Registry last updated
Jul 12, 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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