NCT06545734

Brief Summary

The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC. The primary questions this trial seeks to answer are:

  1. 1.Is direct IPostC effective for acute stroke patients with large vessel occlusion?
  2. 2.What are the underlying mechanisms of direct IPostC?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

August 1, 2024

Last Update Submit

August 8, 2024

Conditions

Stroke, AcuteNeuroprotectionIschemic Conditioning

Keywords

Stroke, Acute; Large Vessel Occlusion; Neuroprotection

Outcome Measures

Primary Outcomes (2)

  • Final Infarct volume

    Infarct volume at 24 (-6/+12) hours postoperatively

    24(-6/+12) hours after procedure

  • Infarct Volume Growth

    Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours

    24(-6/+12) hours after procedure

Secondary Outcomes (5)

  • Change in NIHSS between baseline and 2 hours

    2 hours after procedure

  • Change in NIHSS between baseline and 24 hours

    24 hours after procedure

  • Functional Independence at 90 days

    90 days after randomization

  • Functional Independence at 5 days or discharge

    5 days or at discharge after randomization

  • Blood brain barrier permeability at 72 hours

    72 hours after procedure

Other Outcomes (4)

  • Difference in Peripheral circulating immune cells counts

    1, 3 and 5 days after procedure

  • Difference in lymphocyte phenotyping

    PBMC isolated from peripheral venous blood at 24 hours

  • Difference in expression of genes associated with T cell polarization

    PBMC isolated from peripheral venous blood at 24 hours

  • +1 more other outcomes

Study Arms (2)

Endovascular therapy

ACTIVE COMPARATOR
Procedure: Endovascular therapy

Endovascular therapy plus direct ischemic post-conditioning

EXPERIMENTAL
Procedure: Direct Ischemic Post-conditioningProcedure: Endovascular therapy

Interventions

Direct Ischemic Post-conditioningPROCEDURE

After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.

Endovascular therapy plus direct ischemic post-conditioning
Endovascular therapyPROCEDURE

Thrombectomy alone.

Endovascular therapyEndovascular therapy plus direct ischemic post-conditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke confirmed by CT or MRI.
  • Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).
  • \. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
  • \. The patient or legally authorized representative has signed an informed consent form.

You may not qualify if:

  • Inability to perform an MRI or CT scan for any reason.
  • Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
  • Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
  • Pregnancy.
  • Presence of other serious, advanced, or terminal illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300070, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ming Wei, MD, PhD

CONTACT

13502182903drweiming@163.com

Yongbo Xu, MD

CONTACT

17361616533yonbur@outlook.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 9, 2024

Study Start

February 5, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Locations

CN(1)