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Chronic Intracranial Artery OcclusionNCT07699003

Endovascular Treatment of Chronic Intracranial Artery Occlusion

A study testing Endovascular treatment and Standard pharmacological treatment in people with Chronic Intracranial Artery Occlusion, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Intracranial Artery Occlusion
What is being tested?
Endovascular treatment and Standard pharmacological treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
382 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age ≥18 years
  • Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)
  • Modified Rankin Scale (mRS) score of 0-2
  • Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment
  • The subject or their legally authorised representative has provided written informed consent for the study

Who cannot join

  • Evidence of hemorrhage on CT or MRI
  • Large hemispheric infarction involving >50% of the middle cerebral artery territory on CT or MRI
  • Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy <12 months
  • Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)
  • Uncontrolled seizure at the time of stroke onset
  • Baseline platelet count <50,000/μL
Show all 16Show fewer
  • Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg)
  • Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) >3
  • Suspected septic emboli or suspected bacterial endocarditis
  • Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures
  • Pregnant women
  • Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy <24 months
  • Prior attempted endovascular recanalization therapy before randomization
  • Current participation in other studies involving investigational drugs or devices
  • Evidence of intracranial tumour on CT or MRI (except meningioma)
  • Excessive tortuosity of cervical vessels on CTA/MRA that may preclude endovascular therapy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bo Hu, Doctor contact

+86 13707114863

hubo@mail.hust.edu.cn

About this study

Official title: Endovascular Treatment of Chronic Intracranial Artery Occlusion: A Multicenter Randomized Controlled Trial

Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.

Read the detailed description

This study is a multicenter, outcome-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular therapy combined with standard medical therapy versus standard medical therapy alone in patients with chronic intracranial artery occlusion. A total of 382 patients (191 per group) aged ≥18 years with chronic occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery confirmed by CTA, MRA, or DSA will be enrolled and randomly assigned to the experimental group (endovascular therapy + standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is stroke or death within 30 days after enrollment, or any ischemic stroke related to the responsible artery occurring from 30 days to 12 months after enrollment. Secondary endpoints include any stroke or death within 30 days after randomization; any stroke within 12 months after the procedure; disabling stroke within 12 months after the procedure; fatal stroke within 12 months after the procedure; any death within 12 months after the procedure; mRS score at 12 months; NIHSS score at 12 months; successful reperfusion rate of endovascular therapy; and procedure-related complications.

Being tested
Endovascular treatment, Standard pharmacological treatment
Keywords
Chronic Intracranial Artery Occlusion, stroke
Medical subject headings
Stroke

What participants receive

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

  • Endovascular treatmentProcedure or surgery

    Endovascular recanalization therapy for chronic atherosclerotic intracranial artery occlusion, including balloon angioplasty and/or stent implantation (e.g., self-expanding or drug-eluting stents) targeting the occluded unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery. The procedure is performed under local or general anesthesia via femoral or radial arterial access, with peri-procedural dual antiplatelet therapy (e.g., aspirin plus clopidogrel) management according to standard institutional protocols.

  • Standard pharmacological treatmentDrug

    Standard pharmacological treatment: dual antiplatelet (aspirin 100 mg + clopidogrel 75 mg daily) for first 90 days, then single antiplatelet; high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily) targeting LDL-C <1.8 mmol/L; strict BP control (<140/90 mmHg, or <130/80 mmHg in diabetics) and glycemic control (HbA1c <7.0%); uniformly applied across centers with pill-count adherence monitoring.

Study groups in NCT07699003
Study groupRoleWhat they receive
Test groupExperimentalEndovascular treatment combined with standard pharmacological treatment
Receives: Procedure: Endovascular treatment
control groupOtherStandard pharmacological treatment
Receives: Drug: Standard pharmacological treatment

What is being measured

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

  1. Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment

    A stroke is defined as rapid loss of neurological function due to ischaemia or a haemorrhage. CT or MRI scanning is necessary to identify the stroke.

    Measured: Within 30 days post-enrollment; and 30 days to 12 months post-enrollment

Secondary outcomes (10)

  1. Disabling stroke within 12 months post-procedure

    Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. CT or MR scans will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.

    Measured: 12 months post-procedure

  2. Successful reperfusion rate

    Measured: End of the procedure

  3. Any stroke within 12 months post-procedure

    Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. Additional key neuro-images (CT or MR scans) will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.

    Measured: 12 months post-procedure

  4. Residual stenosis of target vessel at 12 months

    The degree of target artery stenosis based on following-up neurovascular imaging

    Measured: 12 months post-procedure

  5. Fatal stroke within 12 months post-procedure

    A cerebrovascular event that directly causes death or leads to irreversible brain damage resulting in imminent death based on CT or MR scans

    Measured: 12 months post-procedure

  6. NIHSS score at 12 months

    The National Institutes of Health Stroke Scale (NIHSS) Scores range from a minimum of 0 (normal) to a maximum of 42 (profound impairment). Higher scores indicate a worse outcome, as they correspond to more severe stroke symptoms and poorer long-term prognosis.

    Measured: 12 months post-procedure

  7. mRS score at 12 months

    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: 12 months post-procedure

  8. Any death within 12 months post-procedure

    Measured: 12 months post-procedure

  9. Any stroke or death within 30 days post-randomization

    Measured: Within 30 days post-randomization

  10. Procedure-related complications

    Measured: Perioperative period / Within 30 days post-procedure

Timeline

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

  1. First posted13 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completion1 Aug 2030 (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
382 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699003
Sponsor's protocol ID
ETP-C
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
13 Jul 2026
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 pharmacological treatment in people with Chronic Intracranial Artery Occlusion, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Bo Hu, 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?

Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment (time frame: Within 30 days post-enrollment; and 30 days to 12 months post-enrollment). 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 NCT07699003.

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 13 Jul 2026.

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