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Acute Ischemic StrokeETP-1NCT06580730

Endovascular Treatment for Stroke Post 1 Day （24 Hours）

A study testing Endovascular treatment and Standard medical treatment in people with Acute Ischemic Stroke, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Endovascular treatment and Standard medical treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
1 Sep 2024to 1 Aug 2026
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Age≥18 and ≤80
  • Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization
  • Stroke onset or more than 24 hours from the last known well state and within 30 days.
  • Pre-stroke mRS score of 0 or 1 points
  • The subject or their legally authorized representative has signed the informed consent form for the study
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  • Imaging Inclusion Criteria
  • Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA), or Digital Subtraction Angiography (DSA) confirms the occlusion of major intracranial vessels (occlusion of the internal carotid artery and/or the middle cerebral artery M1/M2 segment)
  • Meets one of the following imaging evaluation criteria:
  • <!-- -->
  • Assessed by Computed Tomography Perfusion (CTP) or Perfusion Weighted Imaging (PWI) with MRI: Infarct core volume is less than 100 mL and the mismatch ratio is ≥1.2 or the mismatch volume is ≥10 mL.
  • Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:
  • Infarct volume is less than 30 mL and NIHSS score is ≥10;
  • Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20

Who cannot join

  • General Exclusion Criteria
  • In the judgment of the clinician responsible for treatment, it is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥2), high likelihood of early death)
  • Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
  • Rapid improvement in neurologic status to NIHSS<6 or evidence of vascular reconstruction before randomization
  • Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
  • Baseline platelet count<50,000/uL
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  • Severe persistent hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure>120 mmHg)
  • Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) >3
  • Suspected septic emboli, suspected bacterial endocarditis
  • Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
  • Pregnant women
  • Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
  • Attempt to use a neurothrombectomy device to remove the blood clot before randomization
  • Currently participating in other studies of investigational drugs or devices
  • Any other conditions that, in the opinion of the investigator, would impede endovascular surgery or pose a significant risk to the subject during endovascular surgery
  • Imaging Exclusion Criteria
  • Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;
  • Evidence of intracranial tumors as shown by CT or MRI (except for small meningiomas);
  • CTA/MRA showing excessive tortuosity of the cervical vessels, which may hinder endovascular treatment;
  • Suspected aortic dissection based on medical history and CTA/MRA;
  • Presence of an intracranial stent in the same vascular area, which would impede the smooth progress of surgery.

Trial locations and contacts

1 site in 1 country.

Hubo, Doctor contact

+86 13707114863

hubo@mail.hust.edu.cn

China1 site

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

Other trials in China

About this study

Official title: Endovascular Treatment Post 1 Day （24 Hours）: a Randomized Controlled Clinical Trial on Efficacy and Safety for Stroke

Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Currently, the time window for endovascular treatment in the anterior circulation can be extended up to 24 hours. Exploring endovascular treatments for patients beyond this time window (from 24 hours to 30 days) could mean hope for a greater number of AIS patients.

Being tested
Endovascular treatment, Standard medical treatment
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Endovascular treatmentProcedure or surgery

    Also called mechanical revascularization

    Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.

  • Standard medical treatmentOther

    Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.

Study groups in NCT06580730
Study groupRoleWhat they receive
Test groupExperimentalEndovascular treatment combined with standard medical treatment
Receives: Procedure: Endovascular treatment
Control groupOtherStandard medical treatment
Receives: Other: Standard medical treatment

What is being measured

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

  1. The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90

    Modified Rankin Scale：1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6

    Measured: 90days

Secondary outcomes (18)

  1. Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.

    1. No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. Moderate disability. Requires some help, but able to walk unassisted.
    4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. Dead.

    Measured: 90days

  2. Sustained vessel recanalization rate at 90 days

    Assessment on the 90th day via MRA or CTA

    Measured: 90days

  3. Assessment of activities of daily living at 90 days

    Barthel Index

    Measured: 90days

  4. Proportion with "early improvement" between day 2-7 post-randomization/discharge

    Defined as a decrease of ≥4 points from baseline in NIHSS or an NIHSS score of 0 or 1

    Measured: 2-7days

  5. Difference in median infarct volume size at 24 (-6/+24) hours post-randomization

    Assessment of the infarct volume through imaging (MRI)

    Measured: 24hours

  6. Vessel recanalization at 24 (-6/+24) hours post-randomization

    assessed by MRA/CTA

    Measured: 24hours

  7. EQ-5D-5L questionnaire score at 90 days

    EQ-5D-5L Scales

    Measured: 90days

  8. Montreal Cognitive Assessment (MoCA) score at 90 days

    Montreal Cognitive Assessment (MoCA)

    Measured: 90days

  9. Mini-Mental State Examination (MMSE) score at 90 days

    Mini-Mental State Examination (MMSE)

    Measured: 90days

  10. Stroke-related mortality at 90 days

    Measured: 90days

  11. All-cause mortality at 90 days

    Measured: 90days

  12. New stroke or TIA within 90 days

    The patient had a transient ischemic attack, symptoms of cerebral infarction, or the presence of cerebral infarction confirmed by imaging

    Measured: 90days

  13. Symptomatic intracranial hemorrhage (sICH)

    Defined as a worsening of 4 or more points on the NIHSS within 24 (-6/+24) hours post-randomization and associated with cerebral hemorrhage

    Measured: 24hours

  14. Substantial hematoma type 2 within 24 (-6/+24) hours post-randomization

    Substantial hematoma type 2, accounting for more than 30% of the infarct area, with associated space-occupying effect and leading to clinical condition deterioration

    Measured: 24hours

  15. Neurological deterioration

    Defined as an increase of ≥4 points in NIHSS score from baseline

    Measured: 2-7days

  16. For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke

    according to the ASITN/SIR collateral grading scale

    Measured: Post procedure 24hours

  17. Procedure-related complications

    1. Distal embolization in different regions; b) Iatrogenic arterial dissection; c) Arterial perforation; d) Access site complications of interventional treatment

    Measured: Post procedure 24hours

  18. For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage)

    eTIMI grade ≥2b

    Measured: Post procedure 24hours

Timeline

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

  1. First posted30 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06580730
Sponsor's protocol ID
ETP-1
Acronym
ETP-1
Status last verified
Aug 2024
First submitted
24 Aug 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular treatment and Standard medical treatment in people with Acute Ischemic Stroke, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Hubo, Doctor (+86 13707114863, hubo@mail.hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (time frame: 90days). 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 NCT06580730.

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 5 Sep 2024.

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