Menu
Recruiting NCT06902415

Application of QDSA Platform in Cerebrovascular Diseases

— Observational Cerebrovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QDSA (Quantitative Digital Subtraction Angiography).
Who it may be relevant to
Registry conditions: Cerebrovascular Disease. Basic parameters: 1 year — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Research on the Application of Quantitative Digital Subtraction Angiography Hemodynamic Analysis Platform in Cerebrovascular Diseases

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Symptomatic stroke or death [Time frame: After treatment (max 10 years)]
Secondary outcome measures (1)
  • Neurological status (modified Ranking Scale score) [Time frame: After treatment (max 10 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06902415 · KY2024-371-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗