Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis

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.

NCT Number	NCT07309705
Lead Sponsor	Xuanwu Hospital, Beijing Collaborators: Suining Hospital of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Zhengzhou University, Xuanwu Jinan Hospital, The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Chongqing Medical University, Jiangmen Central Hospital, Hebi People's Hospital, Shanghai Sixth People's Hospital Anhui Branch
Conditions	Intracranial Atherosclerosis ICAS, Hemodynamic, Stroke
Enrollment	400 participants
Start Date	2025-12-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2028-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-30