NCT06902415

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2025Feb 2030

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

March 24, 2025

Last Update Submit

March 24, 2025

Conditions

Cerebrovascular Disease

Keywords

Cerebrovascular DiseaseQuantitative Digital Subtraction AngiographyHemodynamicStrokeDeathOutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Neurological status (modified Ranking Scale score)

    After treatment (max 10 years)

Study Arms (1)

Testing populations

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

Device: QDSA (Quantitative Digital Subtraction Angiography)

Interventions

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.

Testing populations

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Cerebrovascular DisordersStrokeDeath

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yu Chen, MD

CONTACT

86-18801239327chenyu_tiantan@126.com

Xiaolin Chen, MD

CONTACT

86-13810624845cxl_bjtth@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

CN(1)