NCT05024292

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2022Apr 2027

First Submitted

Initial submission to the registry

August 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

4.9 years

First QC Date

August 22, 2021

Last Update Submit

July 10, 2023

Conditions

Ischemic Stroke

Keywords

acute ischemic strokethrombectomythrombolysisoutcome

Outcome Measures

Primary Outcomes (1)

  • functional independence

    mRS 0-2

    3 month

Secondary Outcomes (6)

  • excellent functional independence

    3 month

  • early therapeutic response

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

  • Mortality

    3 month

  • hemorrhagic transformation

    24 hours after treatment

  • Symptomatic intracerebral hemorrhage (sICH)

    24 hours after treatment

  • +1 more secondary outcomes

Study Arms (2)

rapid local ischemic postconditioning (RL-IPostC) group

RL-IPostC is 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.

Procedure: rapid local ischemic postconditioning (RL-IPostC)

control group

no intervention was provided after successful reperfusion

Interventions

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

rapid local ischemic postconditioning (RL-IPostC) group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

RECRUITING

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200233, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

thrombus retrieved from the occluded artery. Serum collected from the vein at different time points.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yueqi Zhu, PhD

    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    STUDY CHAIR

Central Study Contacts

Yueqi Zhu, PhD

CONTACT

+86-21-18930177565zhuyueqi@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated dean of the radiology

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 27, 2021

Study Start

January 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

CN(2)