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Not yet recruitingNCT05974033Updated Aug 3, 2023

IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

An interventional study of Stenting plus medical therapy and Medical therapy alone in ICAS - Intracranial Atherosclerosis, sponsored by Changhai Hospital. Not yet recruiting. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
536
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study summary

A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.

Read the detailed description

The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening.

For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects.

For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.

02

Conditions studied

  • ICAS - Intracranial Atherosclerosis

Keywords

  • ICAS
  • Cerebral Arteriosclerosis
03

In context

Intracranial Arteriosclerosis

97 studies on the registry are indexed under Intracranial Arteriosclerosis; 43 are open to participants now.

This study's planned enrollment of 536 is above the median of 180 across 59 interventional studies indexed under Intracranial Arteriosclerosis.

Browse Intracranial Arteriosclerosis studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥30 and ≤80 years old.
  2. Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, and basilar artery) within the past 3 months.
  3. Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria).
  4. Patients with ischemic stroke should be performed with stenting beyond a duration of 2 weeks from the latest ischemic symptom onset, patients with TIA have no time restriction.
  5. Pre-enrollment modified Rankin Scale (mRS) score ≤2.
  6. Target vessel reference diameter must be measured to be 2 mm to 4.5 mm, target area of stenosis is less than or equal to 14mm in length.
  7. Patients required to meet at least with one atherosclerotic risk factors, including hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, smoking history, and atherosclerosis in other arterial vessels.
  8. Negative pregnancy test in a female who has had any menses in the last 18 months.
  9. Patient is willing and able to return for all follow-up visits required by the protocol.
  10. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc.
  2. Any conditions that precludes proper angiographic assessment.
  3. Preoperative MRI indicating only lacunar infarction in the target lesion territory.
  4. History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage.
  5. At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct area diameter >5 cm); hemorrhagic transformation of an ischemic stroke within the past 15 days (detected by CT).
  6. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
  7. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and occipital symptoms).
  8. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date.
  9. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion
  10. Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement.
  11. Presence of intraluminal thrombus proximal to or at the target lesion.
  12. Any aneurysm proximal to or distal to intracranial stenotic artery.
  13. Intracranial tumors or any intracranial vascular malformations.
  14. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
  15. Myocardial infarction within previous 30 days.
  16. Suspected severe allergy or contraindication to vascular interventional-related drugs or devices, such as aspirin, clopidogrel, general anesthesia agents, heparin, contrast agents, nitinol alloy, etc.
  17. Active bleeding diathesis or coagulopathy, active gastrointestinal ulcer, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \<100,000, hematocrit \<30, INR >1.5, dysfunctions of the blood coagulation system.
  18. uncontrolled severe hypertension (systolic BP>180mm Hg or diastolic BP>110mm Hg)
  19. Severe comorbidities or unstable conditions, such as severe heart failure, respiratory failure, or renal failure (serum creatinine>264μmol/L, unless on dialysis), severe liver dysfunction (ALT or ALT >3 times normal), malignant tumors.
  20. Major surgery performed within 30 days prior to enrollment or planned inpatient surgery within 90 days after enrollment.
  21. Pregnancy or intent to become pregnant during the trial period.
  22. Currently participating in another clinical trial.
  23. Life expectancy less than 3 years
  24. Patients unable to complete follow-up due to cognitive impairment, emotional disorders, or mental illness.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
536 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Stenting plus medical therapy

    Combination Product: Stenting plus medical therapy

  • Active comparator
    Control group

    Medical therapy alone

    Drug: Medical therapy alone

Interventions

  • Combination productStenting plus medical therapy

    Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.

  • DrugMedical therapy alone

    Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.

06

What researchers measure

Primary outcomes

  1. Stroke or death

    Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.

    Time frame: Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.

Secondary outcomes

  1. Ischemic stroke in the target vessel territory

    Ischemic stroke in the target vessel territory

    Time frame: Within 1-3 years after enrollment

  2. Ischemic stroke in non-target vessel territory

    Ischemic stroke in non-target vessel territory

    Time frame: Within 30 days to 1 year, and within 1-3 years after enrollment

  3. Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage

    Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage

    Time frame: Within 30 days to 3 years after enrollment

  4. Any cause of death

    Any cause of death

    Time frame: Within 30 days to 3 years after enrollment

  5. mRS score

    Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.

    Time frame: At 1 year, 2 years, and 3 years after enrollment

  6. National Institutes of Health Stroke Scale (NIHSS) score

    Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.

    Time frame: At 1 year, 2 years, and 3 years after enrollment

  7. Barthel Index

    An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome.

    Time frame: At 1 year, 2 years, and 3 years after enrollment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data sharing will be available from 12 months after the publication of the main results.

Access criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses

Data sharing details ↗ · www.ocin.org.cn

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05974033
Lead sponsor
Changhai Hospital
Responsible party
Sponsor
First posted
Aug 3, 2023
Start date
Aug 2023 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 3, 2023

Study contacts

Pengfei Yang, M.D.
Contact
15921196312@163.com
86-21-31161784
Jianimin Liu, M.D.
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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