NCT07309705Active, not recruiting
Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis
Digital Angiography-Based Hemodynamic Assessment for Stroke Risk Stratification in Intracranial Arterial Stenosis
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Stroke
- NCT number
- NCT07309705
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Dec 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-atherosclerotic intracranial stenosis such as moyamoya disease, vasculitis, or arterial dissection.
- 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.
Other
- 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.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery, Xuanwu hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.