NCT06769867

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

January 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

January 2, 2025

Last Update Submit

March 13, 2025

Conditions

Cerebrovascular Disease

Keywords

CerebrovascularAI3D-DSA

Outcome Measures

Primary Outcomes (1)

  • The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    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.

    No more than 6 hours

Secondary Outcomes (1)

  • The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    No more than 1 month

Other Outcomes (1)

  • Comparison of image quality using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    No more than 1 month

Study Arms (2)

PS-3D-DSA

EXPERIMENTAL

undergo a PS-3D-DSA scan

Radiation: PS-3D-DSA

classic 3D-DSA

SHAM COMPARATOR

undergo a classic 3D-DSA scan

Radiation: classic 3D-DSA

Interventions

PS-3D-DSARADIATION

undergo a PS-3D-DSA scan

PS-3D-DSA
classic 3D-DSARADIATION

undergo a classic 3D-DSA scan

classic 3D-DSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Requires 3D-DSA-guided interventional diagnosis or treatment (e.g., cerebral angiography, cerebral artery chemoembolization) and meets operational indications.
  • Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.

You may not qualify if:

  • Severe heart or lung disease, such as heart failure or chronic obstructive pulmonary disease (COPD).
  • History of high-dose radiation exams or treatments.
  • Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.
  • Pregnant or breastfeeding women.
  • Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).
  • Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (2)

  • van Asch CJ, Velthuis BK, Rinkel GJ, Algra A, de Kort GA, Witkamp TD, de Ridder JC, van Nieuwenhuizen KM, de Leeuw FE, Schonewille WJ, de Kort PL, Dippel DW, Raaymakers TW, Hofmeijer J, Wermer MJ, Kerkhoff H, Jellema K, Bronner IM, Remmers MJ, Bienfait HP, Witjes RJ, Greving JP, Klijn CJ; DIAGRAM Investigators. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: prospective, multicentre cohort study. BMJ. 2015 Nov 9;351:h5762. doi: 10.1136/bmj.h5762.

    PMID: 26553142BACKGROUND

  • Irfan M, Malik KM, Ahmad J, Malik G. StrokeNet: An automated approach for segmentation and rupture risk prediction of intracranial aneurysm. Comput Med Imaging Graph. 2023 Sep;108:102271. doi: 10.1016/j.compmedimag.2023.102271. Epub 2023 Jul 22.

    PMID: 37556901BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Huangxuan Zhao, PhD

CONTACT

+86 18627162379zhao_huangxuan@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 10, 2025

Study Start

April 15, 2025

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)