Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis (NCT07309705) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis
China400 participantsStarted 2025-12-01
Plain-language summary
The goal of this observational study is to learn whether a digital angiography derived fractional flow reserve (DPR) measurement can improve the prediction of stroke risk in adults with symptomatic intracranial atherosclerotic stenosis, defined as 50 to 99 percent narrowing.
The main questions it aims to answer are:
Does DPR identify patients who are at higher risk of recurrent stroke despite receiving standard medical treatment? Is DPR more accurate than traditional angiographic stenosis measurements for assessing the functional severity of intracranial arterial disease?
Participants will undergo routine digital subtraction angiography as part of their clinical evaluation. Their angiographic images will be analyzed using a computational method to estimate blood flow impairment, and they will be followed for up to 12 months to monitor stroke related outcomes.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients with intracranial atherosclerotic stenosis (ICAS) of the anterior circulation.
✓. History of an ischemic cerebrovascular event related to the target artery within the past 12 months, including ischemic stroke involving less than one-half of the middle cerebral artery territory or transient ischemic attack.
✓. Age between 18 and 80 years.
✓. Stenosis severity of 50% to 99% identified by transcranial Doppler ultrasound, CT angiography, or MR angiography, and confirmed as 50% to 99% stenosis on digital subtraction angiography.
✓. Good compliance, willingness to sign written informed consent, and ability to complete follow-up.
Exclusion criteria
✕. Non-atherosclerotic intracranial stenosis such as moyamoya disease, vasculitis, or arterial dissection.
✕. Coexisting ipsilateral arterial stenosis greater than 50% other than the target lesion.
✕. Large territorial infarction on MRI DWI involving at least one-half of the MCA territory with a modified Rankin Scale score greater than 3.
What they're measuring
1
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
✕. Contraindications to the use of antiplatelet agents or statins.
✕. Inability to undergo DSA because of severe iodinated contrast allergy, severe hyperthyroidism, severe coagulation abnormalities with high bleeding risk, or severe cardiac, hepatic, or renal insufficiency.