AISICAS LVO-MTNCT06702657
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy
A study testing balloon dilatation and/or stenting and medication in people with AIS and ICAS - Intracranial Atherosclerosis, run by Changhai Hospital.
Trial summary
A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIS, ICAS - Intracranial Atherosclerosis, Stroke
- What is being tested?
- balloon dilatation and/or stenting and medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical inclusion criteria:
- Age ≥ 18 years
- National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
- To receive mechanical thrombectomy <24 hours after AIS onset according to local guidelines
- Signed informed consent form obtained from the subject (or approved surrogate)
- Imaging inclusion criteria:
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- For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
- For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) < 3 based on CT or DWI
- Angiography inclusion criteria:
- The responsible occluded vessel is immediately recanalized (eTICI≥2b) after mechanical thrombectomy, ICAS is highly suspected and the focal residual stenosis of the main trunk is≥70%, and the responsible occluded vessels include the intracranial segment of the internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery
- According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty
Who cannot join
- Pre-stroke mRS >2
- Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
- Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
- Tandem lesions: stenosis (or occlusion) of the extracranial segment of the internal carotid artery or vertebral artery combined with occlusion of large intracranial vessels, stenosis of intracranial arteries combined with occlusion of vessels distal to the stenosis
- More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
- Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
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- Current use of oral anticoagulants
- Major surgery or serious trauma in the previous 2 weeks
- Contraindication for mechanical thrombectomy or stenting angioplasty
- Contraindication for antiplatelet treatment or allergy to contrast agent
- History of gastrointestinal or urinary bleeding in the previous 3 weeks
- Life expectancy less than 1 years
- Current pregnant or breastfeeding status
- Currently participating in another clinical trial that may affect the outcome assessment of this trial
- Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.
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
Official title: A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)
A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial
Read the detailed description
The main objective of AIS ICAS-MT study is to evaluate whether direct stenting, compared with medical therapy can benefit patients with acute ischemic stroke caused by CTA-confirmed large vessel occlusion (intracranial segments ICA, M1, BA, V4) who have been successfully recanalized by mechanical thrombectomy (MT) and are judged to be in situ ICAS lesions.
Primary outcomes: Functional recovery, defined as a sequence shift (improvement) in scores on the mRS at 90 (±14) days.
Secondary outcomes:
- Rate of good functional outcome (mRS of 0-2) at 90±14 days
- Rate of excellent functional outcome (mRS of 0-1) at 90±14 days
- Change in stroke severity (NIHSS score) at 24±12 hours
- Change in stroke severity (NIHSS score) at 7±2 days or discharge
- Proportion of target vessel recanalisation (eTICI≥2b) at 5±2 days confirmed by CTA
- Final infarct volume at 5±2 days
- EuroQol Five Dimensions (EQ-5D) Score at 90±14 days
- Barthel Index at 90±14 days
- mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
- Stroke between 90 days and 365 days
- mRS Score shift at 365±30 days as an ordinal variable
- Rate of good functional outcome (mRS of 0-2) at 365±30 days
- Rate of excellent functional outcome (mRS of 0-1) at 365±30 days
- EuroQol Five Dimensions (EQ-5D) Score at 365±30 days
- Barthel Index at 365±30 days
Safety outcomes:
- Deaths within 90±14 days after enrolment
- Intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first)
- SAEs within 90±14 days after enrolment
- Any procedural complications
- The occurrence of new ischaemic stroke in the downstream territory of the occluded vessel within 90±14 days after enrolment
- Any cause of death within 365±30 days after enrolment
- Any occurrence of intracranial hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 365±30 days after enrolment
- Conditions
- AIS, ICAS - Intracranial Atherosclerosis, Stroke
- Being tested
- balloon dilatation and/or stenting, medication
- Keywords
- ICAS, AIS, STROKE
- Medical subject headings
- Intracranial Arteriosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon dilatation and/or stentingDevice
balloon dilatation and/or stenting immediately after randomization
medicationDrug
medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: balloon dilatation and/or stenting |
| Control group | Active comparator | Not described Receives: Drug: medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery
defined as a sequence shift (improvement) in scores on the mRS
Measured: 90(±14) days
Secondary outcomes (15)
Rate of good functional outcome
mRS of 0-2
Measured: 90 (±14) days
Rate of excellent functional outcome
mRS 0-1
Measured: 90(±14) days
Change in stroke severity (NIHSS score)
Measured: 24±12 hours
Change in stroke severity (NIHSS score)
Measured: 7±2 days or discharge
Proportion of target vessel recanalisation (eTICI≥2b)
Measured: 5±2 days
Final infarct volume
Measured: 5±2 days
EuroQol Five Dimensions (EQ-5D) Score
Measured: 90 (±14) days
Barthel Index
Measured: 90 (±14) days
mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
Measured: 365days
Stroke
Measured: between 90 days and 365 days
mRS Score shift
Measured: 365 (±30)days
Rate of good functional outcome
mRS of 0-2
Measured: 365 (±30) days
Rate of excellent functional outcome
mRS of 0-1
Measured: 365 (±30) days
EuroQol Five Dimensions (EQ-5D) Score
Measured: 365 (±30) days
Barthel Index
Measured: 365 (±30) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Mar 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AISStudies 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
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Changzhou
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, MD, PhD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702657
- Sponsor's protocol ID
- ICAS LVO-MT
- Acronym
- ICAS LVO-MT
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2024
- Last updated
- 18 Mar 2025
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)
- ClinicalTrials.gov ID
- NCT06702657
- Acronym / sponsor ID
- ICAS LVO-MT / ICAS LVO-MT
- Conditions
- AIS, ICAS - Intracranial Atherosclerosis, Stroke
- Keywords
- ICAS, AIS, STROKE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First People's Hospital of Changzhou
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 25 Nov 2024 (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 prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial
Detailed description
The main objective of AIS ICAS-MT study is to evaluate whether direct stenting, compared with medical therapy can benefit patients with acute ischemic stroke caused by CTA-confirmed large vessel occlusion (intracranial segments ICA, M1, BA, V4) who have been successfully recanalized by mechanical thrombectomy (MT) and are judged to be in situ ICAS lesions.
Primary outcomes: Functional recovery, defined as a sequence shift (improvement) in scores on the mRS at 90 (±14) days.
Secondary outcomes:
- Rate of good functional outcome (mRS of 0-2) at 90±14 days
- Rate of excellent functional outcome (mRS of 0-1) at 90±14 days
- Change in stroke severity (NIHSS score) at 24±12 hours
- Change in stroke severity (NIHSS score) at 7±2 days or discharge
- Proportion of target vessel recanalisation (eTICI≥2b) at 5±2 days confirmed by CTA
- Final infarct volume at 5±2 days
- EuroQol Five Dimensions (EQ-5D) Score at 90±14 days
- Barthel Index at 90±14 days
- mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
- Stroke between 90 days and 365 days
- mRS Score shift at 365±30 days as an ordinal variable
- Rate of good functional outcome (mRS of 0-2) at 365±30 days
- Rate of excellent functional outcome (mRS of 0-1) at 365±30 days
- EuroQol Five Dimensions (EQ-5D) Score at 365±30 days
- Barthel Index at 365±30 days
Safety outcomes:
- Deaths within 90±14 days after enrolment
- Intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first)
- SAEs within 90±14 days after enrolment
- Any procedural complications
- The occurrence of new ischaemic stroke in the downstream territory of the occluded vessel within 90±14 days after enrolment
- Any cause of death within 365±30 days after enrolment
- Any occurrence of intracranial hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 365±30 days after enrolment
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 | Device: balloon dilatation and/or stenting |
| Control group | Active comparator | Drug: medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
- To receive mechanical thrombectomy <24 hours after AIS onset according to local guidelines
- Signed informed consent form obtained from the subject (or approved surrogate)
- For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
Key exclusion criteria (15 listed)
- Pre-stroke mRS >2
- Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
- Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
- Tandem lesions: stenosis (or occlusion) of the extracranial segment of the internal carotid artery or vertebral artery combined with occlusion of large intracranial vessels, stenosis of intracranial arteries combined with occlusion of vessels distal to the stenosis
- More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
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 |
|---|---|---|
| balloon dilatation and/or stentingballoon dilatation and/or stenting immediately after randomization | Device | Intervention group |
| medicationmedication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting. | Drug | Control group |
Primary outcome
Functional recovery
Time frame: 90(±14) days
defined as a sequence shift (improvement) in scores on the mRS
15 secondary outcomes
Rate of good functional outcome
Time frame: 90 (±14) days
Rate of excellent functional outcome
Time frame: 90(±14) days
Change in stroke severity (NIHSS score)
Time frame: 24±12 hours
Change in stroke severity (NIHSS score)
Time frame: 7±2 days or discharge
Proportion of target vessel recanalisation (eTICI≥2b)
Time frame: 5±2 days
Final infarct volume
Time frame: 5±2 days
EuroQol Five Dimensions (EQ-5D) Score
Time frame: 90 (±14) days
Barthel Index
Time frame: 90 (±14) days
mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
Time frame: 365days
Stroke
Time frame: between 90 days and 365 days
mRS Score shift
Time frame: 365 (±30)days
Rate of good functional outcome
Time frame: 365 (±30) days
Rate of excellent functional outcome
Time frame: 365 (±30) days
EuroQol Five Dimensions (EQ-5D) Score
Time frame: 365 (±30) days
Barthel Index
Time frame: 365 (±30) days
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 18 Mar 2025.
- 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.
Jianmin Liu, MD, PhD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing balloon dilatation and/or stenting and medication in people with AIS and 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 11 inclusion and 15 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 18 Mar 2025. 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, MD, PhD (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?
Functional recovery (time frame: 90(±14) days). 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 18 Mar 2025.