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IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT) | Clinical Trials | Clareo Health

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

NCT05974033•Changhai Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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

•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.
+14 more criteria

Key Dates

Start Date

August 1, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2027

Last Updated

August 3, 2023

Enrollment

536

ESTIMATED participants

Conditions

ICAS - Intracranial Atherosclerosis

Interventions

Stenting plus medical therapy

COMBINATION_PRODUCT

Medical therapy alone

DRUG

Contacts

Pengfei Yang, M.D.

CONTACT

86-21-31161784 15921196312@163.com

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

NCT04948749

ICAD - Intracranial Atherosclerotic DiseaseICAS - Intracranial Atherosclerosis+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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