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Stroke AcutePhase 2NCT06967025

Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy

A Phase 2 study testing Ischemic Postconditioning and Endovascular Thrombectomy in people with Stroke Acute and Cytoprotection, run by Tianjin Huanhu Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial will evaluate whether on-site ischemic postconditioning (IPostC) improves outcomes in acute stroke patients receiving endovascular thrombectomy (EVT) and explore its mechanisms. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ischemic Postconditioning and Endovascular Thrombectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
12 Sep 2024to 15 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is ≥ 18 years of age.
  • The patient must have symptoms consistent with AIS (i.e. face drooping, arm weakness, speech difficulty, etc.) , with symptoms severity of baseline NIHSS ≥ 6 and beginning less than 24 hours prior to presentation at hospital.
  • Pre-stroke mRS ≤ 2.
  • Baseline ASPECTS ≥ 6.
  • Unilateral middle cerebral artery occlusion, and/or internal carotid artery occlusion.
  • The patient is eligible for EVT.
  • Successful recanalization achieved through EVT (eTICI 2b-3).
  • The patient is willing to provide written informed consent to participate in this clinical trial.

Who cannot join

  • The interventionalist deems the study device unable to reach the target site.
  • Adverse events related to thrombectomy, such as contrast extravasation, vascular rupture/perforation, dissection, or embolization to a new territory, detected on post-thrombectomy angiography.
  • Stent placement performed in the M1 segment of the middle cerebral artery or the terminal segment of the internal carotid artery during thrombectomy.
  • Angioplasty of more than two cycles of balloon inflation/deflation.
  • The patient is experiencing cardiogenic shock, systolic blood pressure [SBP] <100 mmHg, HR>100 bpm and arterial oxygen saturation (pulse oximetry) <92% without additional oxygen.
  • The patient has known history of Congestive Heart Failure, hepatic failure, end-stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m²).
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  • The patient is febrile (temperature > 37.5 °C) or has experienced an infection with fever in the last 5 days.
  • The patient has a known hypersensitivity or contraindication to aspirin, heparin, Clopidogrel, tirofiban, or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
  • The patient has a pre-AIS life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
  • The patient is currently enrolled in another investigational drug or device trial.
  • The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy.
  • The patient is a female who is known to be pregnant.
  • Other conditions deemed unsuitable for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300700

Other trials in China

About this study

Official title: Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy: Mechanistic Exploration Through a Randomized Controlled Pilot Trial

This clinical trial will evaluate whether on-site ischemic postconditioning (IPostC) improves outcomes in acute stroke patients receiving endovascular thrombectomy (EVT) and explore its mechanisms. The investigators aim to answer: (1) Is on-site IPostC effective compared to EVT alone? (2) What molecular markers and cellular pathways does on-site IPostC influence? Participants will be randomized to EVT alone or EVT+IPostC (4 cycles of 2-minute balloon occlusion/reperfusion). The investigators will assess infarct size, functional outcomes, biomarkers (e.g., multi-omics, ELISA, and clinical laboratory parameters), and safety (e.g., mortality, procedure-related complications).

Read the detailed description

This clinical trial is a single-center, prospective, blind endpoint, randomized -controlled trial. Randomization will be in a 1:1 ratio, Intervention Arm (EVT + on-site IPostC) or Control Arm (EVT alone) in up to a total of 60 patients (30 subjects in each arm). On-site IPostC will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus, consisting of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion).

Being tested
Ischemic Postconditioning, Endovascular Thrombectomy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ischemic PostconditioningProcedure or surgery

    Ischemic Postconditioning will consist of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion), and will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus.

  • Endovascular ThrombectomyProcedure or surgery

    Thrombectomy alone.

Study groups in NCT06967025
Study groupRoleWhat they receive
Endovascular thrombectomyActive comparatorNot described
Receives: Procedure: Endovascular Thrombectomy
Ischemic Postconditioning plus Endovascular thrombectomyExperimentalNot described
Receives: Procedure: Ischemic Postconditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infarct volume growth

    Measured: Difference between infarct volume at 48 (-12/+24) hours post-randomization and baseline.

Secondary outcomes (7)

  1. Final infarct volume

    Measured: At 48 (-12/+24) hours post-randomization.

  2. Immediate postprocedural infarct volume

    Measured: Within 2 hours post-randomization.

  3. Difference in modified Rankin Scale distribution

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The distribution of mRS scores (0-6) will be compared between treatment groups.

    Measured: At 90 days post-randomization.

  4. Difference in modified Rankin Scale of 0-1

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-1 will be compared between treatment groups.

    Measured: At 90 days post-randomization.

  5. Difference in modified Rankin Scale of 0-2

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-2 will be compared between treatment groups.

    Measured: At 90 days post-randomization.

  6. Occurrence of early neurological improvement

    The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. Early neurological improvement is defined as a reduction in NIHSS score by ≥8 points.

    Measured: within 24 hours post-randomization.

  7. Longitudinal Change of NIHSS Scores

    The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. NIHSS scores will be serially assessed at specified intervals.

    Measured: At 24 hours, 3 days, and 5-7 days post-randomization or at discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start12 Sep 2024
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967025
Sponsor's protocol ID
tjhh20249
Status last verified
Sep 2024
First submitted
16 Apr 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Plan Description: De-identified individual participant data (IPD) will not be made publicly available due to unresolved ethical considerations regarding data anonymization feasibility and institutional policies. A formal evaluation of data sharing options will be conducted post-study completion. Access Criteria: Not applicable. IPD sharing is currently restricted. Future access may be negotiated via institutional data governance committees upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ischemic Postconditioning and Endovascular Thrombectomy in people with Stroke Acute and Cytoprotection, run by Tianjin Huanhu Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct volume growth (time frame: Difference between infarct volume at 48 (-12/+24) hours post-randomization and baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06967025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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