Application of QDSA Platform in Cerebrovascular Diseases (RADAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Device: QDSA (Quantitative Digital Subtraction Angiography)

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yu Chen, MD; Phone Number: 86-18801239327; Email: chenyu_tiantan@126.com
• Study Contact Backup: Name: Xiaolin Chen, MD; Phone Number: 86-13810624845; Email: cxl_bjtth@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Yu Chen, MD; Phone Number: 86-18801239327; Email: chenyu_tiantan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA.

Description

Inclusion Criteria:

1. Cerebrovascular diseases diagnosed and assessed by DSA for related risks and treatment options.
2. The DSA acquisition protocol complies with the standard procedure.
3. DSA images must include complete anteroposterior and lateral views.
4. Raw data must be available in DICOM format.
5. Image quality and pixel resolution must support data analysis.
6. Patients must undergo regular follow-ups.

Exclusion Criteria:

1. Cerebrovascular diseases not diagnosed or risk-assessed using DSA.
2. Patients with DSA image quality insufficient for image analysis and processing.
3. Severe organ diseases with an expected survival period of less than 2 years.
4. Inability to cooperate with treatment and follow-up.
5. Participation in other clinical trials within the past 6 months.
6. Other conditions deemed by the investigator as unsuitable for participation in this trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Testing populations; Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After treatment (max 10 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After treatment (max 10 years)

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Hemodynamic; Outcome; Death; Cerebrovascular Disease; Quantitative Digital Subtraction Angiography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: KY2024-371-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No