Application of QDSA Platform in Cerebrovascular Diseases (RADAR)

Capital Medical University

Status

Enrolling

Conditions

Cerebrovascular Disease

Treatments

Device: QDSA (Quantitative Digital Subtraction Angiography)

Study type

Observational

Funder types

Other

Identifiers

NCT06902415

KY2024-371-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

1 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.