Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis

NCT07309705 | Active Not Recruiting DMC

• 2 other identifiers: CASSISS-DPRWKZX2025CZ0401
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodynamic; Stroke; Intracranial Atherosclerosis ICAS

Keywords

Intracranial Atherosclerotic Stenosis; Recurrent Stroke Risk; Hemodynamic Impairment; Fractional Flow Reserve; Precision Risk Stratification

Outcome Measures

Primary Outcomes (1)

• ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

  the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

  Baseline to 12 months (±2 months)

Secondary Outcomes (5)

• transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year

  Baseline to 12 months (±2 months)

• TIA related to ischemia in the qualifying artery territory within 1 year

  Baseline to 12 months (±2 months)

• any stroke/TIA/ death within 1 year

  Baseline to 12 months (±2 months)

• hemodynamic ischemic stroke in the qualifying artery territory within 1 year

  Baseline to 12 months (±2 months)

• embolic stroke within in the qualifying artery territory 1 year

  Baseline to 12 months (±2 months)

Study Arms (1)

CASSISS-DPR

Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention

Interventions

Standardized medical therapy targeting vascular risk factors and stroke prevention DRUG

Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines

CASSISS-DPR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 18 to 80 years with symptomatic intracranial atherosclerotic stenosis (50%-99%) of a major anterior-circulation artery, who experienced a target-artery-related ischemic event (ischemic stroke involving \<50% MCA territory or TIA) within the past 12 months and are eligible for medical therapy and DPR evaluation.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• Xuanwu Hospital, Beijing: lead
• Suining Hospital of Traditional Chinese Medicine: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Xuanwu Jinan Hospital: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Jiangmen Central Hospital: collaborator
• Hebi People's Hospital: collaborator
• Shanghai Sixth People's Hospital Anhui Branch: collaborator

Study Sites (1)

Department of Neurosurgery, Xuanwu hospital

Beijing, Xicheng District, 100053, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)