Digital Angiography-Derived Fractional Flow Assessment for Intracranial Stenosis (CASSISS-DPR)

December 15, 2025 updated by: Xuanwu Hospital, Beijing

Digital Angiography-Based Hemodynamic Assessment for Stroke Risk Stratification in Intracranial Arterial 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intracranial atherosclerotic stenosis (ICAS) is a major cause of ischemic stroke, representing ~15% of cases in Western populations and up to 46.6% in Asia. Even with intensive medical therapy, annual stroke recurrence remains high (7.2-20%), prompting exploration of additional treatment strategies. Early trials such as SAMMPRIS and VISSIT suggested worse outcomes with stenting compared with aggressive medical therapy, largely due to concerns over operator experience, patient selection, and timing. Subsequent analyses showed that patients with hemodynamic compromise-such as watershed infarction and poor collaterals-have recurrence rates up to 37%, underscoring the central role of impaired cerebral perfusion.

Although more recent studies (CASSISS, BASIS) demonstrated that endovascular therapy may be safe and effective in carefully selected patients, current ICAS assessment relies primarily on stenosis severity, which correlates only weakly with true hemodynamic impairment and is insufficient for accurate risk stratification. Because symptoms arise principally from reduced perfusion, physiologic evaluation is essential.

Fractional flow reserve (FFR) is the gold standard for assessing coronary lesion significance and guiding intervention through translesional pressure gradients. Attempts to translate this approach to ICAS using invasive pressure wires have shown feasibility but remain limited by anatomical differences, lack of dedicated devices, procedural risks, and unclear outcome thresholds.

Our prior work demonstrated that intracranial translesional pressure gradients correlate strongly with cerebral blood flow in both animal models and clinical settings, validating hemodynamic relevance. To overcome the limitations of invasive measurements, the present study seeks to develop and evaluate a noninvasive, angiography-derived pressure ratio (DPR) using routine digital subtraction angiography. This method allows physiologic assessment without pressure wires and may reduce procedural risk.

The objectives of this project are to establish a computational DPR technique, determine its association with clinical outcomes, identify a hemodynamic threshold for stroke-risk stratification, and validate its performance in a prospective multicenter cohort. By enabling early identification of high-risk ICAS patients who may respond poorly to medical therapy, DPR has the potential to improve treatment selection and outcomes, ultimately advancing strategies for stroke prevention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Xicheng District
      • Beijing, Xicheng District, China, 100053
        • Department of Neurosurgery, Xuanwu hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Patients with intracranial atherosclerotic stenosis (ICAS) of the anterior circulation.
  2. 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.
  3. Age between 18 and 80 years.
  4. 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.
  5. Good compliance, willingness to sign written informed consent, and ability to complete follow-up.

Exclusion Criteria:

  1. Non-atherosclerotic intracranial stenosis such as moyamoya disease, vasculitis, or arterial dissection.
  2. Coexisting ipsilateral arterial stenosis greater than 50% other than the target lesion.
  3. Large territorial infarction on MRI DWI involving at least one-half of the MCA territory with a modified Rankin Scale score greater than 3.
  4. Contraindications to the use of antiplatelet agents or statins.
  5. 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.
  6. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CASSISS-DPR
Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention
Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
Time Frame: Baseline to 12 months (±2 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year
Time Frame: Baseline to 12 months (±2 months)
the number of participants who suffer from transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year after enrollment.
Baseline to 12 months (±2 months)
TIA related to ischemia in the qualifying artery territory within 1 year
Time Frame: Baseline to 12 months (±2 months)
the number of participants who suffer from 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
Time Frame: Baseline to 12 months (±2 months)
the number of participants who suffer from any stroke/TIA/ death within 1 year
Baseline to 12 months (±2 months)
hemodynamic ischemic stroke in the qualifying artery territory within 1 year
Time Frame: Baseline to 12 months (±2 months)
the number of participants who suffer from 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
Time Frame: Baseline to 12 months (±2 months)
the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year
Baseline to 12 months (±2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of University of Science and Technology of China
Jiangmen Central Hospital
Nanfang Hospital, Southern Medical University
Xuanwu Jinan Hospital
Suining Hospital of Traditional Chinese Medicine
Hebi People's Hospital
Shanghai Sixth People's Hospital Anhui Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASSISS-DPR
  • WKZX2025CZ0401 (Other Grant/Funding Number: Development Center for Medical Science & Technology National Health Commission of the People's Republic of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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