ICAS - Intracranial AtherosclerosisNCT05974033
IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)
A study testing Stenting plus medical therapy and Medical therapy alone in people with ICAS - Intracranial Atherosclerosis, run by Changhai Hospital.
Trial summary
A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- ICAS - Intracranial Atherosclerosis
- What is being tested?
- Stenting plus medical therapy and Medical therapy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2027
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥30 and ≤80 years old.
- 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.
- Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria).
- 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.
- Pre-enrollment modified Rankin Scale (mRS) score ≤2.
- 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.
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- 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.
- Negative pregnancy test in a female who has had any menses in the last 18 months.
- Patient is willing and able to return for all follow-up visits required by the protocol.
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
Who cannot join
- 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.
- Any conditions that precludes proper angiographic assessment.
- Preoperative MRI indicating only lacunar infarction in the target lesion territory.
- 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.
- 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).
- Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
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- 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).
- Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date.
- 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
- Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement.
- Presence of intraluminal thrombus proximal to or at the target lesion.
- Any aneurysm proximal to or distal to intracranial stenotic artery.
- Intracranial tumors or any intracranial vascular malformations.
- Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
- Myocardial infarction within previous 30 days.
- 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.
- 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.
- uncontrolled severe hypertension (systolic BP>180mm Hg or diastolic BP>110mm Hg)
- 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.
- Major surgery performed within 30 days prior to enrollment or planned inpatient surgery within 90 days after enrollment.
- Pregnancy or intent to become pregnant during the trial period.
- Currently participating in another clinical trial.
- Life expectancy less than 3 years
- Patients unable to complete follow-up due to cognitive impairment, emotional disorders, or mental illness.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- ICAS - Intracranial Atherosclerosis
- Being tested
- Stenting plus medical therapy, Medical therapy alone
- Keywords
- ICAS, Cerebral Arteriosclerosis
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting plus medical therapyCombination product
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.
Medical therapy aloneDrug
Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Stenting plus medical therapy Receives: Combination Product: Stenting plus medical therapy |
| Control group | Active comparator | Medical therapy alone Receives: Drug: Medical therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
Ischemic stroke in the target vessel territory
Ischemic stroke in the target vessel territory
Measured: Within 1-3 years after enrollment
Ischemic stroke in non-target vessel territory
Ischemic stroke in non-target vessel territory
Measured: Within 30 days to 1 year, and within 1-3 years after enrollment
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Measured: Within 30 days to 3 years after enrollment
Any cause of death
Any cause of death
Measured: Within 30 days to 3 years after enrollment
mRS score
Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
Measured: At 1 year, 2 years, and 3 years after enrollment
National Institutes of Health Stroke Scale (NIHSS) score
Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
Measured: At 1 year, 2 years, and 3 years after enrollment
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.
Measured: At 1 year, 2 years, and 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICAS - Intracranial AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianimin Liu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974033
- Sponsor's protocol ID
- ICAS-MT
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)
- ClinicalTrials.gov ID
- NCT05974033
- Acronym / sponsor ID
- ICAS-MT
- Conditions
- ICAS - Intracranial Atherosclerosis
- Keywords
- ICAS, Cerebral Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: Stenting plus medical therapyStenting plus medical therapy |
| Control group | Active comparator | Drug: Medical therapy aloneMedical therapy alone |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥30 and ≤80 years old.
- 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.
- Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria).
- 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.
- Pre-enrollment modified Rankin Scale (mRS) score ≤2.
Key exclusion criteria (24 listed)
- 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.
- Any conditions that precludes proper angiographic assessment.
- Preoperative MRI indicating only lacunar infarction in the target lesion territory.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stenting plus medical therapyPatients 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. | Combination product | Intervention group |
| Medical therapy aloneMedical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation. | Drug | Control group |
Primary outcome
Stroke or death
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.
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.
7 secondary outcomes
Ischemic stroke in the target vessel territory
Time frame: Within 1-3 years after enrollment
Ischemic stroke in non-target vessel territory
Time frame: Within 30 days to 1 year, and within 1-3 years after enrollment
Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
Time frame: Within 30 days to 3 years after enrollment
Any cause of death
Time frame: Within 30 days to 3 years after enrollment
mRS score
Time frame: At 1 year, 2 years, and 3 years after enrollment
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: At 1 year, 2 years, and 3 years after enrollment
Barthel Index
Time frame: At 1 year, 2 years, and 3 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianimin Liu, M.D. principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Stenting plus medical therapy and Medical therapy alone in people with ICAS - Intracranial Atherosclerosis, run by Changhai Hospital.
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 10 inclusion and 24 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 3 Aug 2023. 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 Pengfei Yang, M.D. (86-21-31161784, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or death (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.