DSANCT07824739
AI Assistance for Detecting Active Bleeding During DSA Procedures
A study testing DSA-VDet v1.0 in people with DSA and Bleeding, run by Zhongda Hospital at 1 site in China.
Trial summary
Clinically, DSA-VDet can continuously indicate suspected bleeding regions throughout a complete angiographic sequence and provide a second-reader opinion to the operator. It is expected to reduce the time required for frame-by-frame review and localization of culprit vessels, reduce missed detection of small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DSA, Bleeding, AI (Artificial Intelligence)
- What is being tested?
- DSA-VDet v1.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,324 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older;
- suspected acute active bleeding in an intracranial, solid-organ, pelvic, gastrointestinal, respiratory, great-vessel, or other relevant anatomical region requiring DSA-guided interventional diagnosis or treatment;
- clinical suitability for the planned DSA procedure;
- written informed consent from the patient or legally authorized representative before randomization whenever feasible, or eligibility for an ethics-approved deferred-consent pathway at an activated site when prior consent is impossible and treatment cannot be delayed.
Who cannot join
- a history of severe allergic reaction to iodinated contrast medium or related medications that precludes the planned procedure;
- severe coagulopathy or a platelet count below 50x10^9/L when interventional treatment is considered clinically inappropriate;
- severe cardiac or pulmonary insufficiency that makes the planned procedure unsafe;
- pregnancy or breastfeeding;
- severe renal insufficiency or another condition that may substantially increase interventional risk;
- inability to complete angiography safely according to the required workflow despite clinically appropriate support;
- any other circumstance that, in the investigator's judgment, makes participation unsuitable. Impaired decision-making capacity alone will not be an exclusion if consent can be obtained from a legally authorized representative or through the ethics-approved deferred-consent pathway.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda hospital
Nanjing, Jiangsu, 213003
Jun-Hao Mei, 15052007938, jh_mei240225@126.com
About this study
Official title: Real-Time DSA-VDet Assistance for Detecting Active Bleeding Across Multiple Anatomical Regions: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Controlled Trial
Clinically, DSA-VDet can continuously indicate suspected bleeding regions throughout a complete angiographic sequence and provide a second-reader opinion to the operator. It is expected to reduce the time required for frame-by-frame review and localization of culprit vessels, reduce missed detection of small, multiple, or unusually located bleeding sites, and improve consistency among physicians with different levels of experience. Faster culprit-vessel localization may also reduce repeat angiography, radiation exposure, and unnecessary superselective catheterization. These potential benefits will be tested in the prospective randomized trial; the study does not assume that the model will necessarily improve clinical outcomes. From a translational perspective, the study will establish a standardized temporal DSA database spanning multiple centers, devices, and anatomical regions, together with bleeding-site annotation standards, a model suitable for real-time deployment, and a pathway for clinical evaluation. These resources may provide a reproducible technical foundation for regional collaboration in emergency interventional care and AI-assisted interpretation in lower-resource hospitals.
The core value of this study is therefore to address the 'single-region, weak-temporal, algorithm-centered, clinically under-evaluated' limitations of existing models. Using multicenter DSA videos from multiple anatomical regions, the study will leverage contrast kinetics and motion information to improve detection of small bleeding sites and will progress from retrospective validation through controlled physician interpretation to a prospective randomized trial, providing a continuous evaluation from technical performance to clinical benefit.
- Conditions
- DSA, Bleeding, AI (Artificial Intelligence), Hemorrhage, Acute Bleeding
- Being tested
- DSA-VDet v1.0
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA-VDet v1.0Device
During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices. The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions.
| Study group | Role | What they receive |
|---|---|---|
| DSA-VDet-assisted group | Experimental | During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices. The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions. Receives: Device: DSA-VDet v1.0 |
| Conventional-interpretation group | No intervention | The operator will perform frame-by-frame interpretation using the conventional DSA equipment and established workflow, without access to DSA-VDet output. Images may undergo offline model analysis after completion of the index procedure for exploratory purposes, but those results must not be available for the index clinical decision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
To determine whether real-time DSA-VDet v1.0 assistance shortens the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint, compared with conventional interpretation.
Measured: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
Secondary outcomes (4)
the detection and localization performance of DSA-VDet
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Measured: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
effects on interpretation accuracy
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Measured: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interpretation time
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Measured: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interobserver agreement among interventional physicians with different levels of experience
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Measured: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Lu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824739
- Sponsor's protocol ID
- DSA-VDet
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No