An observational study in Embolism Arterial, sponsored by Chongli Yu. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Chongli Yu · Observational
Facial vascular embolism following hyaluronic acid injection is a rare but potentially serious complication that may lead to tissue ischemia, necrosis, and scarring. Early assessment of local tissue perfusion is important for evaluating treatment response and predicting clinical outcomes.
This retrospective observational study aims to evaluate whether indocyanine green angiography (ICGA) can provide objective, real-time information on tissue perfusion in patients with facial vascular embolism after hyaluronic acid injection. The study will review existing medical records, ICGA imaging data, and follow-up information from patients treated at a single center. The main question is whether ICGA findings before and after initial rescue therapy can help assess early perfusion recovery and identify patients who may require additional intervention or develop persistent tissue damage.
This is a single-center, retrospective, observational study. The study will use existing clinical data generated during prior routine care, including medical records, ICGA imaging data, and follow-up documentation. No additional examinations, treatments, or study-specific follow-up visits will be introduced.
The study focuses on patients with facial vascular embolism following hyaluronic acid injection who underwent ICGA assessment before and immediately after initial rescue therapy. ICGA was performed as part of prior clinical evaluation to visualize local tissue perfusion in real time. Quantitative perfusion-related parameters were obtained using imaging analysis software.
The analysis will compare ICGA-based perfusion changes within the same patient before and after initial rescue therapy. The study will also explore whether baseline perfusion status and early perfusion recovery are associated with subsequent clinical management and tissue outcomes. Patients may be descriptively stratified according to whether additional intervention was required after initial rescue therapy.
All data will be collected retrospectively and de-identified before analysis. The study does not alter previous clinical decision-making and does not expose participants to additional physiological risk. The main study-related risk is potential loss of confidentiality, which will be minimized through de-identification, restricted access to study data, and secure data storage.
Chongli Yu is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of consecutive patients treated at the Center for Wound Repair and Tissue Regeneration, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, for facial vascular embolism following hyaluronic acid injection between July 2025 and March 2026. Participants will be identified retrospectively from existing medical records, indocyanine green angiography imaging data, treatment records, and follow-up documentation generated during routine clinical care.
Exclusion Criteria:
Indocyanine green angiography was performed as part of prior routine clinical evaluation to assess local tissue perfusion in patients with facial vascular embolism following hyaluronic acid injection. In this retrospective observational study, existing ICGA imaging data obtained before and immediately after initial rescue therapy will be reviewed and analyzed. No additional ICGA examination will be performed for research purposes.
Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy
Ingress rate is an indocyanine green angiography-derived perfusion parameter representing the maximum slope of fluorescence intensity increase. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in ingress rate, calculated as the post-treatment value minus the pre-treatment value.
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy
Time to peak is an indocyanine green angiography-derived perfusion parameter representing the time interval from first visible fluorescence to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in time to peak, calculated as the post-treatment value minus the pre-treatment value.
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy
Curve ingress is an indocyanine green angiography-derived perfusion parameter representing the area under the fluorescence-time curve from the start of fluorescence increase to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in curve ingress, calculated as the post-treatment value minus the pre-treatment value.
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Plan to share: Undecided
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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