Embolism ArterialNCT07581652
ICGA for Vascular Embolism After Hyaluronic Acid Injection
An observational study of Embolism Arterial, run by Chongli Yu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolism Arterial
- What is being tested?
- Indocyanine Green Angiography Assessment
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- History of facial hyaluronic acid injection.
- Clinical diagnosis of facial vascular embolism after hyaluronic acid injection, with symptoms or signs such as pain, skin color change, livedo-like discoloration, delayed capillary refill, or tissue ischemia.
- Received initial rescue treatment at the study center.
- Had indocyanine green angiography imaging performed before and immediately after initial rescue treatment as part of routine clinical care.
- Had sufficient medical records and follow-up information available to assess subsequent treatment and tissue outcomes.
Who cannot join
- Incomplete indocyanine green angiography imaging data.
- Insufficient medical records or follow-up information to assess the main study outcomes.
- Missing key clinical information needed for study analysis.
- Duplicate records or records with concerns about data reliability.
- The patient or legal representative explicitly objected to the use of historical clinical data for this study, if applicable under local ethics requirements.
Trial locations and contacts
1 site in 1 country.
China1 site
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100144
About this study
Official title: Value of Indocyanine Green Angiography for Real-Time Assessment of Vascular Embolism Following Hyaluronic Acid Injection
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.
Read the detailed description
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.
- Conditions
- Embolism Arterial
- Being tested
- Indocyanine Green Angiography Assessment
- Keywords
- Indocyanine green angiography, Hyaluronic acid injection, Facial vascular embolism, Hyaluronidase, Rescue therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Angiography AssessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jul 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolism ArterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongli Yu
- Sponsor type
- University, hospital or other
- Collaborators
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Responsible party
- Sponsor-investigator, Chongli Yu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581652
- Sponsor's protocol ID
- 2026042018584440
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Indocyanine Green Angiography for Real-Time Assessment of Vascular Embolism Following Hyaluronic Acid Injection
- ClinicalTrials.gov ID
- NCT07581652
- Acronym / sponsor ID
- 2026042018584440
- Conditions
- Embolism Arterial
- Keywords
- Indocyanine green angiography, Hyaluronic acid injection, Facial vascular embolism, Hyaluronidase, Rescue therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chongli YuUniversity, hospital or other
- Collaborators
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- History of facial hyaluronic acid injection.
- Clinical diagnosis of facial vascular embolism after hyaluronic acid injection, with symptoms or signs such as pain, skin color change, livedo-like discoloration, delayed capillary refill, or tissue ischemia.
- Received initial rescue treatment at the study center.
- Had indocyanine green angiography imaging performed before and immediately after initial rescue treatment as part of routine clinical care.
- Had sufficient medical records and follow-up information available to assess subsequent treatment and tissue outcomes.
Key exclusion criteria (5 listed)
- Incomplete indocyanine green angiography imaging data.
- Insufficient medical records or follow-up information to assess the main study outcomes.
- Missing key clinical information needed for study analysis.
- Duplicate records or records with concerns about data reliability.
- The patient or legal representative explicitly objected to the use of historical clinical data for this study, if applicable under local ethics requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine Green Angiography AssessmentIndocyanine 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. | Other | – |
Primary outcome
Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of 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.
Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of 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.
Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy
Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolism Arterial, run by Chongli Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy (time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.