An observational study in Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Beijing Anzhen Hospital · Observational
The primary design of this study is an ambispective observational cohort study. In patients undergoing successful optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with post-procedural angiographic images suitable for computational analysis, this study aims to evaluate the prognostic value of post-PCI angiography-derived physiological indices, specifically angiography-derived fractional flow reserve (Angio-FFR) and angiography-derived index of microcirculatory resistance (Angio-IMR), beyond conventional clinical risk factors and OCT-derived anatomical parameters. Specifically, the objectives are:
Optical coherence tomography (OCT) provides high-resolution intravascular imaging and enables detailed assessment of stent expansion, stent apposition, and edge-related complications, making it an important tool for optimizing PCI in complex coronary lesions. Contemporary guidelines support intravascular imaging-guided PCI, and OCT-guided PCI has improved the anatomical quality of stent implantation compared with angiography-guided procedures. Nevertheless, adverse cardiovascular events continue to occur in a proportion of patients despite apparently successful OCT-guided PCI, suggesting that anatomical optimization alone may not fully eliminate post-procedural risk.
The final physiological result after PCI is determined not only by the local anatomical result within the treated segment but also by residual diffuse epicardial disease and the status of the coronary microcirculation. Previous studies have shown that residual ischemia and microvascular dysfunction may persist even after angiographically successful PCI. Because OCT primarily evaluates epicardial structural features, it cannot directly assess global physiological reserve or microvascular function. These unrecognized functional abnormalities may therefore represent an important source of residual risk after otherwise anatomically optimized PCI.
Pre-procedural physiologic characterization may further improve understanding of this residual risk. Pullback pressure gradient (PPG) quantifies the longitudinal pattern of coronary pressure loss and helps distinguish focal from diffuse epicardial disease. Lower PPG values suggest a more diffuse disease pattern, in which anatomically successful PCI may still yield limited physiological improvement because pressure loss is distributed along the vessel rather than concentrated at a focal stenosis. By contrast, higher PPG values are more consistent with focal disease and a greater potential for physiological recovery after PCI. Accordingly, pre-PCI PPG may provide complementary baseline information for interpreting residual ischemia after anatomically optimized PCI.
In this context, post-PCI functional assessment may provide clinically relevant complementary information. Angiography-derived fractional flow reserve (Angio-FFR) enables physiological assessment of the epicardial coronary circulation, whereas angiography-derived index of microcirculatory resistance (Angio-IMR) provides an estimate of coronary microvascular function. Both indices can be derived from routine post-procedural angiographic images without additional pressure-wire manipulation or pharmacologically induced hyperemia. In general PCI populations, lower post-PCI physiological values and higher microvascular resistance have been associated with worse clinical outcomes, supporting a complementary rather than competitive relationship between anatomical and physiological assessment.
Nevertheless, the applicability of these findings to patients undergoing OCT-guided PCI remains uncertain. Compared with conventional angiography-guided or mixed PCI cohorts, patients selected for OCT-guided PCI often have more complex lesion characteristics and may achieve a higher level of stent optimization. Accordingly, the distribution, composition, and prognostic relevance of residual functional abnormalities may differ in this specific population. More importantly, it has not been directly established whether Angio-FFR and Angio-IMR continue to provide incremental prognostic information after OCT-defined anatomical optimization has been achieved, whether Angio-IMR offers additional value beyond Angio-FFR in this setting, or whether pre-PCI PPG provides complementary information for identifying patients at risk of suboptimal physiological recovery.
Therefore, this study is designed as a multicenter, ambispective observational cohort study led by the National Clinical Research Center for Cardiovascular Diseases and conducted across multiple collaborating centers in China, integrating retrospective and prospective cohorts of patients undergoing successful OCT-guided PCI. Post-procedural Angio-FFR and Angio-IMR will be derived from angiographic images suitable for computational analysis, and their prognostic value will be evaluated in conjunction with baseline clinical characteristics and OCT-derived anatomical parameters. Pre-PCI PPG will also be explored as an adjunctive baseline physiological marker in multivariable analyses. The primary outcome is Major Adverse Cardiovascular Events (MACE), defined as a composite of all-cause death, spontaneous target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, hospitalization for unstable angina, and hospitalization for heart failure. All enrolled patients will undergo a minimum of 24 months of follow-up. By systematically assessing the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR, while exploring the complementary contribution of pre-PCI PPG, this study aims to provide an evidence base for refined risk stratification and individualized post-PCI management after OCT-guided PCI.
Adult patients with coronary artery disease undergoing successful OCT-guided PCI with stent implantation at participating centers in China, with post-procedural angiographic images suitable for computation of pre-PPG and post-Angio-FFR and post- Angio-IMR.
Inclusion Criteria:-1.Age >= 18 years and \< 85 years. 2.Successful stent implantation under OCT guidance. 3.Availability of at least two optimal post-PCI angiographic projections separated by > 25 degrees and suitable for angiography-derived physiological analysis.
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Exclusion Criteria:1.PCI of the culprit vessel for ST-segment elevation myocardial infarction (STEMI).
2.Cardiogenic shock or requirement for mechanical circulatory support. 3.Life expectancy of less than 1 year. 4.History of coronary artery bypass grafting (CABG). 5.Balloon angioplasty without stent implantation. 6.Severe procedural complications, including intraprocedural death, emergency CABG, or coronary perforation.
7.Target-vessel diameter \< 2.5 mm. 8.Heart failure with New York Heart Association (NYHA) class III-IV symptoms or left ventricular ejection fraction (LVEF) \< 30%.
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Patients who underwent successful OCT-guided PCI with stent implantation during the retrospective study period (January 2020 to March 2026) at participating centers in China where eligible archived angiographic, OCT, and follow-up data are available for analysis.
Procedure: OCT-guided PCI
Patients newly enrolled during the prospective study period (March 2026 to March 2027) at participating centers in China who undergo successful OCT-guided PCI with stent implantation and have post-procedural angiographic images suitable for Angio-FFR and Angio-IMR analysis.
Procedure: OCT-guided PCI
Not applicable as assigned study interventions. This is an observational study. OCT-guided PCI will be performed according to routine clinical practice at each participating center. Coronary angiographic images obtained before and after PCI will be used to derive angiography-based physiologic indices, including pre-PCI pullback pressure gradient (PPG) and post-PCI Angio-FFR and Angio-IMR, for physiologic characterization and outcome analysis.
Major Adverse Cardiovascular Events
MACE is defined as the first occurrence of any of the following events: all-cause death, spontaneous target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, hospitalization for unstable angina, or hospitalization for heart failure.
Time frame: Up to 24 months after the index PCI
All-cause death
Occurrence of death from any cause.
Time frame: Up to 24 months after the index PCI
Spontaneous target-vessel myocardial infarction
Spontaneous myocardial infarction involving the target vessel. Periprocedural myocardial infarction will not be included.
Time frame: Up to 24 months after the index PCI
Ischemia-driven target-vessel revascularization
Repeat revascularization of the target vessel performed because of recurrent ischemia.
Time frame: Up to 24 months after the index PCI
Hospitalization for unstable angina
Hospitalization for unstable angina meeting clinical diagnostic criteria.
Time frame: Up to 24 months after the index PCI
Hospitalization for heart failure
Hospitalization for heart failure meeting clinical diagnostic criteria.
Time frame: Up to 24 months after the index PCI
Seattle Angina Questionnaire (SAQ) score
Residual ischemia-related health status assessed using the Seattle Angina Questionnaire across the domains of physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life.
Time frame: At 6, 12, and 24 months after the index PCI
Plan to share: No — Due to patient privacy and ethical restrictions
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Beijing Anzhen Hospital