Chronic Total Occlusion (CTO)FACT-2NCT07020858
FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion
An observational study of Chronic Total Occlusion (CTO) and Chronic Coronary Syndrome, run by Lin Zhao at 1 site in China.
Trial summary
Prospective, observational, single-center cohort study Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion (CTO), Chronic Coronary Syndrome
- What is being tested?
- FAPl lmaging
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 15 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Who may be able to join
- Age ≥18 years.
- Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA).
- Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.
- Ability to provide written informed consent.
Who cannot join
- Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.
- Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.
- Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Life expectancy <1 year due to non-cardiovascular comorbidities.
- Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital，Capital Medical University，Beijing，China
Beijing, Beijing Municipality, 100020
About this study
Official title: The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)
Prospective, observational, single-center cohort study
Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET/CT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling.
Read more
Inclusion Criteria
- Age ≥ 18 years
- Presence of at least one untreated chronic total occlusion (CTO) lesion in a major coronary artery (diameter ≥ 2.5 mm, TIMI 0 flow for ≥ 3 months) confirmed by coronary angiography or CTCA
- Patient eligible for PCI and undergoing FAPI PET/CT imaging prior to intervention
- Written informed consent provided
Exclusion Criteria
- Allergy or contraindication to antiplatelet agents (aspirin, clopidogrel, or ticagrelor)
- Severe liver dysfunction (liver enzymes >3× upper limit of normal)
- Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
- Estimated life expectancy < 1 year
- Pregnancy or potential for pregnancy
Primary Endpoint Incidence of 1-year MACE, defined as a composite of: Cardiac death, Myocardial infarction, Stroke, Urgent revascularization
Secondary Endpoints
- All-Cause Mortality
- Death from any cause within 12 months
- Quality of Life Change: Measured by Seattle Angina Questionnaire (SAQ): changes in angina frequency, physical limitation, and treatment satisfaction
- Repeat PCI Events: Incidence of: In-stent restenosis (ISR): ≥50% luminal loss in previously stented segment; Target lesion revascularization (TLR): at original PCI lesion; Target vessel revascularization (TVR): other sites in same vessel; De novo lesions: new lesions not previously treated
Sample Size Estimated 470 patients
Follow-Up Duration 12 months post-PCI, One follow-up visit including clinical exam, SAQ questionnaire, imaging (PET/CT, echocardiography), and laboratory testing.
Read the detailed description
Chronic total occlusion (CTO) of coronary arteries represents one of the most complex and challenging subsets of coronary artery disease and is associated with increased cardiovascular risk. While percutaneous coronary intervention (PCI) for CTO lesions has evolved substantially due to advances in imaging, devices, and operator experience, long-term prognostic evaluation remains suboptimal. In particular, no imaging biomarker currently allows non-invasive prediction of major adverse cardiovascular events (MACE) following CTO PCI.
Fibroblast activation plays a central role in myocardial fibrosis and atherosclerotic plaque instability, both of which contribute to adverse cardiovascular outcomes.
The fibroblast activation protein inhibitor (FAPI), labeled with radionuclides for PET/CT imaging, has recently emerged as a promising tool for quantifying fibrotic activity both in the myocardium and within coronary plaques. Preliminary data from the original FACT study showed that FAPI imaging may predict ventricular remodeling 6 months post-PCI. However, its long-term prognostic value and its role in detecting plaque vulnerability have not been fully evaluated in prospective studies.
The FACT-2 study is a prospective observational cohort study designed to evaluate whether FAPI PET/CT imaging can predict 1-year MACE in patients with CTO undergoing PCI. All enrolled patients will undergo baseline 18F-FAPI PET/CT scans prior to PCI and will be followed for 12 months post-intervention. The study aims to establish a FAPI-based risk stratification model, integrating FAPI uptake parameters with plaque morphology (via OCT and histopathology), serological fibrosis markers, and patient-reported quality of life scores.
The primary endpoint of the study is the incidence of MACE, defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization within one year of PCI. Secondary endpoints include all-cause mortality, repeat PCI events (including in-stent restenosis, target lesion/vessel revascularization, and de novo lesion intervention), and quality of life changes assessed by the Seattle Angina Questionnaire (SAQ).
In this study, FAPI uptake will be quantified by multiple parameters including total uptake volume (FAPI%), standardized uptake values (SUVmax, SUVmean), and target-to-background ratio (TBR). These parameters will be analyzed for correlation with clinical outcomes and histopathological features of plaque vulnerability (e.g., positive remodeling, microcalcification, lipid-rich necrotic core). The goal is to determine whether FAPI PET/CT can serve as a novel imaging biomarker for both myocardial and systemic fibrotic activity and stratify future cardiovascular risk.
By addressing the current evidence gaps in CTO prognosis and risk stratification, the FACT-2 study aims to provide scientific and clinical justification for incorporating molecular imaging into routine management of complex coronary artery disease. This study will also contribute to a more personalized treatment paradigm, bridging the gap between anatomical repair and biologically targeted intervention in cardiovascular medicine.
- Being tested
- FAPl lmaging
- Keywords
- Coronary Heart Disease, Major adverse cardiovascular events (MACE), Plaque vulnerability, Optical coherence tomography (OCT), Fibroblast activation protein inhibitor (FAPI), Percutaneous coronary intervention (PCI)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPl lmagingDiagnostic test
Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPl) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPl imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Patients with at least one untreated CTOat basal angiography | Total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter >2.5 mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old Receives: Diagnostic Test: FAPl lmaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization (including in-stent restenosis, target lesion revascularization, or target vessel revascularization). Events will be assessed through clinical follow-up and hospital record review.
Measured: 12 months after percutaneous coronary intervention (PCI)
Secondary outcomes (3)
All-Cause Mortality
Death from any cause, including cardiovascular and non-cardiovascular causes, occurring within 12 months after the index PCI procedure.
Measured: 12 months post-PCI, verified through national death registry and hospital records.
Change in Quality of Life
Assessed using the Seattle Angina Questionnaire (SAQ). Outcome domains include angina frequency, physical limitation, and treatment satisfaction. Comparison is made between baseline and 12-month follow-up.
Measured: At baseline and 12 months post-PCI.
Repeat Percutaneous Coronary Intervention (Repeat PCI)
Incidence of repeat PCI due to recurrent or new coronary lesions within 12 months, categorized as:
In-Stent Restenosis (ISR): ≥50% luminal narrowing in the original stented segment, with or without symptoms.
Target Lesion Revascularization (TLR): Reintervention at the original stent site due to restenosis or thrombosis.
Target Vessel Revascularization (TVR): Intervention in the same coronary artery, but outside the original stent site.
De Novo Lesion: New lesion in a vessel not treated during the index PCI. Confirmation based on follow-up angiography.
Measured: Within 12 months following the index PCI procedure.Angiographic confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Apr 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion (CTO)Studies 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
- Prospective
- Enrolment
- 470 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lin Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Zhao, Beijing Chao Yang Hospital
- Investigators
- Lin Zhao, Dr, Principal investigator, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020858
- Sponsor's protocol ID
- 2025-ke-415
- Acronym
- FACT-2
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
Park TK, Lee SH, Choi KH, Lee JM, Yang JH, Song YB, Hahn JY, Choi JH, Gwon HC, Lee SH, Choi SH. Late Survival Benefit of Percutaneous Coronary Intervention Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion: A 10-Year Follow-Up Study. J Am Heart Assoc. 2021 Mar 16;10(6):e019022. doi: 10.1161/JAHA.120.019022. Epub 2021 Mar 4.
PubMed 33660515Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, Di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO). EuroIntervention. 2023 Sep 18;19(7):571-579. doi: 10.4244/EIJ-D-23-00312.
PubMed 37482940Yang L, Guo L, Lv H, Liu X, Zhong L, Ding H, Zhou X, Zhu H, Huang R. Predictors of Adverse Events Among Chronic Total Occlusion Patients Undergoing Successful Percutaneous Coronary Intervention and Medical Therapy. Clin Interv Aging. 2021 Oct 14;16:1847-1855. doi: 10.2147/CIA.S337069. eCollection 2021.
PubMed 34703218
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)
- ClinicalTrials.gov ID
- NCT07020858
- Acronym / sponsor ID
- FACT-2 / 2025-ke-415
- Keywords
- Coronary Heart Disease, Major adverse cardiovascular events (MACE), Plaque vulnerability, Optical coherence tomography (OCT), Fibroblast activation protein inhibitor (FAPI), Percutaneous coronary intervention (PCI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Lin ZhaoUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 13 Jun 2025 (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.
Prospective, observational, single-center cohort study
Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET/CT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling.
Inclusion Criteria
- Age ≥ 18 years
- Presence of at least one untreated chronic total occlusion (CTO) lesion in a major coronary artery (diameter ≥ 2.5 mm, TIMI 0 flow for ≥ 3 months) confirmed by coronary angiography or CTCA
- Patient eligible for PCI and undergoing FAPI PET/CT imaging prior to intervention
- Written informed consent provided
Exclusion Criteria
- Allergy or contraindication to antiplatelet agents (aspirin, clopidogrel, or ticagrelor)
- Severe liver dysfunction (liver enzymes >3× upper limit of normal)
- Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
- Estimated life expectancy < 1 year
- Pregnancy or potential for pregnancy
Primary Endpoint Incidence of 1-year MACE, defined as a composite of: Cardiac death, Myocardial infarction, Stroke, Urgent revascularization
Secondary Endpoints
- All-Cause Mortality
- Death from any cause within 12 months
- Quality of Life Change: Measured by Seattle Angina Questionnaire (SAQ): changes in angina frequency, physical limitation, and treatment satisfaction
- Repeat PCI Events: Incidence of: In-stent restenosis (ISR): ≥50% luminal loss in previously stented segment; Target lesion revascularization (TLR): at original PCI lesion; Target vessel revascularization (TVR): other sites in same vessel; De novo lesions: new lesions not previously treated
Sample Size Estimated 470 patients
Follow-Up Duration 12 months post-PCI, One follow-up visit including clinical exam, SAQ questionnaire, imaging (PET/CT, echocardiography), and laboratory testing.
Detailed description
Chronic total occlusion (CTO) of coronary arteries represents one of the most complex and challenging subsets of coronary artery disease and is associated with increased cardiovascular risk. While percutaneous coronary intervention (PCI) for CTO lesions has evolved substantially due to advances in imaging, devices, and operator experience, long-term prognostic evaluation remains suboptimal. In particular, no imaging biomarker currently allows non-invasive prediction of major adverse cardiovascular events (MACE) following CTO PCI.
Fibroblast activation plays a central role in myocardial fibrosis and atherosclerotic plaque instability, both of which contribute to adverse cardiovascular outcomes.
The fibroblast activation protein inhibitor (FAPI), labeled with radionuclides for PET/CT imaging, has recently emerged as a promising tool for quantifying fibrotic activity both in the myocardium and within coronary plaques. Preliminary data from the original FACT study showed that FAPI imaging may predict ventricular remodeling 6 months post-PCI. However, its long-term prognostic value and its role in detecting plaque vulnerability have not been fully evaluated in prospective studies.
The FACT-2 study is a prospective observational cohort study designed to evaluate whether FAPI PET/CT imaging can predict 1-year MACE in patients with CTO undergoing PCI. All enrolled patients will undergo baseline 18F-FAPI PET/CT scans prior to PCI and will be followed for 12 months post-intervention. The study aims to establish a FAPI-based risk stratification model, integrating FAPI uptake parameters with plaque morphology (via OCT and histopathology), serological fibrosis markers, and patient-reported quality of life scores.
The primary endpoint of the study is the incidence of MACE, defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization within one year of PCI. Secondary endpoints include all-cause mortality, repeat PCI events (including in-stent restenosis, target lesion/vessel revascularization, and de novo lesion intervention), and quality of life changes assessed by the Seattle Angina Questionnaire (SAQ).
In this study, FAPI uptake will be quantified by multiple parameters including total uptake volume (FAPI%), standardized uptake values (SUVmax, SUVmean), and target-to-background ratio (TBR). These parameters will be analyzed for correlation with clinical outcomes and histopathological features of plaque vulnerability (e.g., positive remodeling, microcalcification, lipid-rich necrotic core). The goal is to determine whether FAPI PET/CT can serve as a novel imaging biomarker for both myocardial and systemic fibrotic activity and stratify future cardiovascular risk.
By addressing the current evidence gaps in CTO prognosis and risk stratification, the FACT-2 study aims to provide scientific and clinical justification for incorporating molecular imaging into routine management of complex coronary artery disease. This study will also contribute to a more personalized treatment paradigm, bridging the gap between anatomical repair and biologically targeted intervention in cardiovascular medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with at least one untreated CTOat basal angiography | – | Diagnostic Test: FAPl lmagingTotal occlusion in any major coronary vessel or relevant side branches [reference vessel diameter >2.5 mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA).
- Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.
- Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.
- Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Life expectancy <1 year due to non-cardiovascular comorbidities.
- Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).
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 |
|---|---|---|
| FAPl lmagingStudies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPl) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPl imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases. | Diagnostic test | Patients with at least one untreated CTOat basal angiography |
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months after percutaneous coronary intervention (PCI)
MACE is defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization (including in-stent restenosis, target lesion revascularization, or target vessel revascularization). Events will be assessed through clinical follow-up and hospital record review.
3 secondary outcomes
All-Cause Mortality
Time frame: 12 months post-PCI, verified through national death registry and hospital records.
Change in Quality of Life
Time frame: At baseline and 12 months post-PCI.
Repeat Percutaneous Coronary Intervention (Repeat PCI)
Time frame: Within 12 months following the index PCI procedure.Angiographic confirmation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 33660515Park TK, Lee SH, Choi KH, Lee JM, Yang JH, Song YB, Hahn JY, Choi JH, Gwon HC, Lee SH, Choi SH. Late Survival Benefit of Percutaneous Coronary Intervention Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion: A 10-Year Follow-Up Study. J Am Heart Assoc. 2021 Mar 16;10(6):e019022. doi: 10.1161/JAHA.120.019022. Epub 2021 Mar 4.
- Background: PubMed 37482940Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, Di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO). EuroIntervention. 2023 Sep 18;19(7):571-579. doi: 10.4244/EIJ-D-23-00312.
- Background: PubMed 34703218Yang L, Guo L, Lv H, Liu X, Zhong L, Ding H, Zhou X, Zhu H, Huang R. Predictors of Adverse Events Among Chronic Total Occlusion Patients Undergoing Successful Percutaneous Coronary Intervention and Medical Therapy. Clin Interv Aging. 2021 Oct 14;16:1847-1855. doi: 10.2147/CIA.S337069. eCollection 2021.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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.
Lin Zhao, Dr principal investigator
Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
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 Chronic Total Occlusion (CTO) and Chronic Coronary Syndrome, run by Lin Zhao 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 4 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengwen Yang, Dr (+8601085231480 ext. +8617801014018, verayang1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: 12 months after percutaneous coronary intervention (PCI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07020858, which also lists 3 linked publications.
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 19 Jun 2025.