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(Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction

NCT06769867 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-04-15
Last updated
2025-03-18

Condition(s) studied

Cerebrovascular Disease

Investigational drug(s) / intervention(s)

PS-3D-DSAclassic 3D-DSA

PS-3D-DSA: undergo a PS-3D-DSA scan

classic 3D-DSA: undergo a classic 3D-DSA scan

Study summary

If the participants agree to participate in this study, the participants will undergo two scans (classic 3D-DSA and PS-3D-DSA assisted scan) to compare the imaging effects of both. After the procedure, the investigators will record the radiation exposure and collect DSA images.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age ≥18 years. 2. Requires 3D-DSA-guided interventional diagnosis or treatment (e.g., cerebral angiography, cerebral artery chemoembolization) and meets operational indications. 3. Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form. Exclusion Criteria: 1. Severe heart or lung disease, such as heart failure or chronic obstructive pulmonary disease (COPD). 2. History of high-dose radiation exams or treatments. 3. Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications. 4. Pregnant or breastfeeding women. 5. Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency). 6. Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.

Primary outcome measure(s)

  • The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA) — No more than 6 hours
    Using the built-in radiation monitoring function of interventional surgical equipment (DSA system), the radiation dose (AK,air kerma) received by the patient during the procedure is directly measured and recorded. The collected radiation dose data is documented in the patient's medical records and stored in the research database for subsequent analysis and comparative studies.

Trial sites (1)

FacilityCityRegionStatus
Wuhan Union Hospital Wuhan Hubei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06769867 on ClinicalTrials.gov ↗ ← All trials in China