Cerebrovascular DiseaseRADARNCT06902415
Application of QDSA Platform in Cerebrovascular Diseases
An observational study of Cerebrovascular Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Cerebrovascular diseases pose a major global public health challenge, characterized by exceptionally high mortality and disability rates, with their pathogenesis closely linked to hemodynamic abnormalities. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- QDSA (Quantitative Digital Subtraction Angiography)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA.
Who may be able to join
- Cerebrovascular diseases diagnosed and assessed by DSA for related risks and treatment options.
- The DSA acquisition protocol complies with the standard procedure.
- DSA images must include complete anteroposterior and lateral views.
- Raw data must be available in DICOM format.
- Image quality and pixel resolution must support data analysis.
- Patients must undergo regular follow-ups.
Who cannot join
- Cerebrovascular diseases not diagnosed or risk-assessed using DSA.
- Patients with DSA image quality insufficient for image analysis and processing.
- Severe organ diseases with an expected survival period of less than 2 years.
- Inability to cooperate with treatment and follow-up.
- Participation in other clinical trials within the past 6 months.
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
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, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yu Chen, MD, 86-18801239327, chenyu_tiantan@126.com
About this study
Official title: Research on the Application of Quantitative Digital Subtraction Angiography Hemodynamic Analysis Platform in Cerebrovascular Diseases
Cerebrovascular diseases pose a major global public health challenge, characterized by exceptionally high mortality and disability rates, with their pathogenesis closely linked to hemodynamic abnormalities. The quantitative digital subtraction angiography (QDSA) analysis platform, leveraging its advantages of vessel modeling-free operation, high computational efficiency, and DSA-equivalent sensitivity, has emerged as a novel hemodynamic assessment method with significant clinical potential. This study aims to establish a cerebrovascular disease cohort incorporating QDSA parameters to systematically validate the clinical value of this technology in preoperative evaluation and surgical planning, thereby providing evidence-based insights for optimizing diagnostic and therapeutic strategies.
Read the detailed description
Study overview: This study will construct a prospective cohort dataset that comprehensively integrates DSA features, clinical baseline data, clinical manifestations, and follow-up data. Using QDSA technology, hemodynamic parameters of patients will be extracted. Based on multidimensional data, this study will conduct clinical research targeting different clinical scenarios, covering disease natural history evaluation, risk factor analysis, and treatment efficacy assessment. Through longitudinal tracking of data evolution and multidimensional parameter correlation analysis, this framework aims to establish an evidence-based pathway for translating hemodynamic characteristics into clinical decision-making, providing valuable references for clinical practice.
Sample size: Between February 2025 and February 2030, a total of 1000 patients with cerebrovascular diseases will be prospectively enrolled, including those with cerebral arteriovenous malformations (AVMs), cerebral aneurysms, moyamoya disease, cerebral arterial stenosis, ischemic stroke, and other subtypes.
Study endpoints: The primary outcome is defined as the composite endpoint of symptomatic stroke or death. And the secondary outcome included neurological status, assessed using the modified Rankin Scale (mRS).
Follow-up: Follow-up assessments will be conducted at 3 months, 6 months, annually (1 year, 2 years, and 3 years), and every 5 years after the initial treatment decision in the form of telephone interviews or record review. Individuals suspected of experiencing cerebrovascular events will undergo focused documentation during each telephone contact or record review.
- Conditions
- Cerebrovascular Disease
- Being tested
- QDSA (Quantitative Digital Subtraction Angiography)
- Keywords
- Cerebrovascular Disease, Quantitative Digital Subtraction Angiography, Hemodynamic, Stroke, Death, Outcome
- Medical subject headings
- Cerebrovascular Disorders, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QDSA (Quantitative Digital Subtraction Angiography)Device
QDSA is a quantitative analysis technology based on DSA, used to assess hemodynamic characteristics and provide critical data support for the diagnosis and treatment of cerebrovascular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Testing populations | Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA. Receives: Device: QDSA (Quantitative Digital Subtraction Angiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic stroke or death
Stroke is defined as a clinically symptomatic event (any new focal neurological deficit, seizure, or new-onset headache) that is associated with imaging findings of hemorrhage or infarction. Hemorrhage is defined as fresh intracranial blood on head computed tomography (CT) or magnetic resonance imaging (MRI), or in the cerebrospinal fluid. Infarction is defined as a new ischemic lesion on cranial CT or MRI (diffusion-weighted, T2-weighted, or fluid-attenuated inversion recovery MRI).
Measured: After treatment (max 10 years)
Secondary outcomes (1)
Neurological status (modified Ranking Scale score)
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead
Measured: After treatment (max 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902415
- Sponsor's protocol ID
- KY2024-371-02
- Acronym
- RADAR
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Quantitative Digital Subtraction Angiography Hemodynamic Analysis Platform in Cerebrovascular Diseases
- ClinicalTrials.gov ID
- NCT06902415
- Acronym / sponsor ID
- RADAR / KY2024-371-02
- Conditions
- Cerebrovascular Disease
- Keywords
- Cerebrovascular Disease, Quantitative Digital Subtraction Angiography, Hemodynamic, Stroke, Death, Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebrovascular diseases pose a major global public health challenge, characterized by exceptionally high mortality and disability rates, with their pathogenesis closely linked to hemodynamic abnormalities. The quantitative digital subtraction angiography (QDSA) analysis platform, leveraging its advantages of vessel modeling-free operation, high computational efficiency, and DSA-equivalent sensitivity, has emerged as a novel hemodynamic assessment method with significant clinical potential. This study aims to establish a cerebrovascular disease cohort incorporating QDSA parameters to systematically validate the clinical value of this technology in preoperative evaluation and surgical planning, thereby providing evidence-based insights for optimizing diagnostic and therapeutic strategies.
Detailed description
Study overview: This study will construct a prospective cohort dataset that comprehensively integrates DSA features, clinical baseline data, clinical manifestations, and follow-up data. Using QDSA technology, hemodynamic parameters of patients will be extracted. Based on multidimensional data, this study will conduct clinical research targeting different clinical scenarios, covering disease natural history evaluation, risk factor analysis, and treatment efficacy assessment. Through longitudinal tracking of data evolution and multidimensional parameter correlation analysis, this framework aims to establish an evidence-based pathway for translating hemodynamic characteristics into clinical decision-making, providing valuable references for clinical practice.
Sample size: Between February 2025 and February 2030, a total of 1000 patients with cerebrovascular diseases will be prospectively enrolled, including those with cerebral arteriovenous malformations (AVMs), cerebral aneurysms, moyamoya disease, cerebral arterial stenosis, ischemic stroke, and other subtypes.
Study endpoints: The primary outcome is defined as the composite endpoint of symptomatic stroke or death. And the secondary outcome included neurological status, assessed using the modified Rankin Scale (mRS).
Follow-up: Follow-up assessments will be conducted at 3 months, 6 months, annually (1 year, 2 years, and 3 years), and every 5 years after the initial treatment decision in the form of telephone interviews or record review. Individuals suspected of experiencing cerebrovascular events will undergo focused documentation during each telephone contact or record review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing populations | – | Device: QDSA (Quantitative Digital Subtraction Angiography)Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA.
Key inclusion criteria (6 listed)
- Cerebrovascular diseases diagnosed and assessed by DSA for related risks and treatment options.
- The DSA acquisition protocol complies with the standard procedure.
- DSA images must include complete anteroposterior and lateral views.
- Raw data must be available in DICOM format.
- Image quality and pixel resolution must support data analysis.
Key exclusion criteria (6 listed)
- Cerebrovascular diseases not diagnosed or risk-assessed using DSA.
- Patients with DSA image quality insufficient for image analysis and processing.
- Severe organ diseases with an expected survival period of less than 2 years.
- Inability to cooperate with treatment and follow-up.
- Participation in other clinical trials within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QDSA (Quantitative Digital Subtraction Angiography)QDSA is a quantitative analysis technology based on DSA, used to assess hemodynamic characteristics and provide critical data support for the diagnosis and treatment of cerebrovascular diseases. | Device | Testing populations |
Primary outcome
Symptomatic stroke or death
Time frame: After treatment (max 10 years)
Stroke is defined as a clinically symptomatic event (any new focal neurological deficit, seizure, or new-onset headache) that is associated with imaging findings of hemorrhage or infarction. Hemorrhage is defined as fresh intracranial blood on head computed tomography (CT) or magnetic resonance imaging (MRI), or in the cerebrospinal fluid. Infarction is defined as a new ischemic lesion on cranial CT or MRI (diffusion-weighted, T2-weighted, or fluid-attenuated inversion recovery MRI).
1 secondary outcome
Neurological status (modified Ranking Scale score)
Time frame: After treatment (max 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen, MD (86-18801239327, chenyu_tiantan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic stroke or death (time frame: After treatment (max 10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.