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Not yet recruitingNCT06702657ICAS LVO-MTUpdated Mar 18, 2025

A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy

An interventional study of balloon dilatation and/or stenting and medication in AIS, ICAS - Intracranial Atherosclerosis and Stroke, sponsored by Changhai Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

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

Phase
Not applicable
Study type
Interventional
Enrollment
612
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • AIS
  • ICAS - Intracranial Atherosclerosis
  • Stroke

Keywords

  • ICAS
  • AIS
  • STROKE
03

In context

Intracranial Arteriosclerosis

93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.

This study's planned enrollment of 612 is above the median of 194 across 55 interventional studies indexed under Intracranial Arteriosclerosis.

Browse Intracranial Arteriosclerosis studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Clinical inclusion criteria:

  1. Age ≥ 18 years
  2. National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
  3. To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
  4. Signed informed consent form obtained from the subject (or approved surrogate)

Imaging inclusion criteria:

  1. For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
  2. 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:

  1. 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
  2. According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty

Exclusion criteria

Exclusion Criteria:

  1. Pre-stroke mRS >2
  2. Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
  3. Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
  4. 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
  5. More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
  6. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
  7. Current use of oral anticoagulants
  8. Major surgery or serious trauma in the previous 2 weeks
  9. Contraindication for mechanical thrombectomy or stenting angioplasty
  10. Contraindication for antiplatelet treatment or allergy to contrast agent
  11. History of gastrointestinal or urinary bleeding in the previous 3 weeks
  12. Life expectancy less than 1 years
  13. Current pregnant or breastfeeding status
  14. Currently participating in another clinical trial that may affect the outcome assessment of this trial
  15. Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.
05

Study design

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

Study arms

  • Experimental
    Intervention group

    Device: balloon dilatation and/or stenting

  • Active comparator
    Control group

    Drug: medication

Interventions

  • Deviceballoon dilatation and/or stenting

    balloon dilatation and/or stenting immediately after randomization

  • Drugmedication

    medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.

06

What researchers measure

Primary outcomes

  1. Functional recovery

    defined as a sequence shift (improvement) in scores on the mRS

    Time frame: 90(±14) days

Secondary outcomes

  1. Rate of good functional outcome

    mRS of 0-2

    Time frame: 90 (±14) days

  2. Rate of excellent functional outcome

    mRS 0-1

    Time frame: 90(±14) days

  3. Change in stroke severity (NIHSS score)

    Time frame: 24±12 hours

  4. Change in stroke severity (NIHSS score)

    Time frame: 7±2 days or discharge

  5. Proportion of target vessel recanalisation (eTICI≥2b)

    Time frame: 5±2 days

  6. Final infarct volume

    Time frame: 5±2 days

  7. EuroQol Five Dimensions (EQ-5D) Score

    Time frame: 90 (±14) days

  8. Barthel Index

    Time frame: 90 (±14) days

  9. 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

    Time frame: 365days

  10. Stroke

    Time frame: between 90 days and 365 days

  11. mRS Score shift

    Time frame: 365 (±30)days

  12. Rate of good functional outcome

    mRS of 0-2

    Time frame: 365 (±30) days

  13. Rate of excellent functional outcome

    mRS of 0-1

    Time frame: 365 (±30) days

  14. EuroQol Five Dimensions (EQ-5D) Score

    Time frame: 365 (±30) days

  15. Barthel Index

    Time frame: 365 (±30) days

Other outcomes

  1. Deaths

    Time frame: within 90±14 days after enrolment

  2. Intracranial hemorrhage

    Time frame: at 7 days post treatment or discharge (whichever occurs first)

  3. SAEs

    Time frame: within 90±14 days after enrolment

  4. Any procedural complications

    Time frame: Perioperative period

  5. The occurrence of new ischaemic stroke in the downstream territory of the occluded vessel

    Time frame: within 90±14 days after enrolment

  6. Any cause of death

    Time frame: within 365±30 days after enrolment

  7. Any occurrence of intracranial hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage

    Time frame: within 365±30 days after enrolment

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, Sap

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 Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06702657
Lead sponsor
Changhai Hospital
Collaborators
The First People's Hospital of Changzhou
Responsible party
Sponsor
First posted
Nov 25, 2024
Start date
Mar 15, 2025 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Mar 18, 2025

Study contacts

Pengfei Yang, MD, PhD
Contact
15921196312@163.com
86-21-31161784
Jianmin Liu, MD, PhD
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 Mar 2025. You cannot join it, but the record below documents what was studied.

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