Not Yet RecruitingNot Applicable

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

536 participantsStarted 2023-08

Plain-language summary

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

Who can participate

Age range30 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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
✕. 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.

What they're measuring

Stroke or death

Timeframe: 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.

Trial details

NCT IDNCT05974033

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Pengfei Yang, M.D.

86-21-31161784 15921196312@163.com

View on ClinicalTrials.gov More ICAS - Intracranial Atherosclerosis trials