Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))ADOPT-PCINCT07511231
Angiography-Derived Physiological Indices for Outcome Prediction in Patients Undergoing OCT-Guided PCI
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
- What is being tested?
- OCT-guided PCI
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Jul 2029
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
-
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%.
-
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
Beijing Anzhen Hospital, Capital Medical University
Beijing
Chenchen Tu, +8615201648899, tcc2033@mail.ccmu.edu.cn
About this study
Official title: Prognostic Value of Angiography-Derived Physiological Indices in Patients Undergoing OCT-Guided Percutaneous Coronary Intervention
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:
- To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up.
- To evaluate the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR when added to models incorporating baseline clinical characteristics and OCT-derived anatomical parameters for predicting MACE.
- To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.
Read the detailed description
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.
- Being tested
- OCT-guided PCI
- Keywords
- Optical Coherence Tomography, OCT-guided PCI, Angiography-derived Fractional Flow Reserve, Angiography-derived Index of Microcirculatory Resistance, Pullback Pressure Gradient, Major Adverse Cardiovascular Events
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided PCIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | 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. Receives: Procedure: OCT-guided PCI | |
| Prospective cohort | 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. Receives: Procedure: OCT-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months after the index PCI
Secondary outcomes (6)
All-cause death
Occurrence of death from any cause.
Measured: 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.
Measured: Up to 24 months after the index PCI
Ischemia-driven target-vessel revascularization
Repeat revascularization of the target vessel performed because of recurrent ischemia.
Measured: Up to 24 months after the index PCI
Hospitalization for unstable angina
Hospitalization for unstable angina meeting clinical diagnostic criteria.
Measured: Up to 24 months after the index PCI
Hospitalization for heart failure
Hospitalization for heart failure meeting clinical diagnostic criteria.
Measured: 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.
Measured: At 6, 12, and 24 months after the index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- min zhang, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511231
- Sponsor's protocol ID
- BeijingAnzhen3
- Acronym
- ADOPT-PCI
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient privacy and ethical restrictions
Publications
Ikeda K, Mizukami T, Sakai K, Bouisset F, Sonck J, Wilgenhof A, Matsuo H, Shinke T, Ando H, Hada M, Ko B, Biscaglia S, Rivero F, Engstrom T, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Keulards D, Zimmermann FM, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson TW, Munhoz D, Amano T, Perera D, Jeremias A, Ali ZA, Kubo T, Satomi K, Tanaka N, De Bruyne B, Johnson NP, Collet C. Impact of Pullback Pressure Gradient on Clinical Outcomes after Percutaneous Coronary Interventions. Circ Cardiovasc Interv. 2025 Dec;18(12):e016022. doi: 10.1161/CIRCINTERVENTIONS.125.016022. Epub 2025 Oct 25.
PubMed 41137850Johnson TW, Bergmark BA, Croce K, Pellegrini D, Maehara A, Gori T, Pinilla-Echeverri N, Wollmuth J, Gonzalo N, Kao HL, Guagliumi G, Phalakornkule K, Ediebah D, McNutt J, Chiu WC, Op den Buijs J, Buccola J, Landmesser U, Ali Z, Stone GW, Jeremias A. Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy. J Am Coll Cardiol. 2025 Jul 15;86(2):93-102. doi: 10.1016/j.jacc.2025.05.019. Epub 2025 May 22.
PubMed 40406943Wang D, Li X, Feng W, Zhou H, Peng W, Wang X. Diagnostic and prognostic value of angiography-derived index of microvascular resistance: a systematic review and meta-analysis. Front Cardiovasc Med. 2024 Apr 15;11:1360648. doi: 10.3389/fcvm.2024.1360648. eCollection 2024.
PubMed 38685980Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.
PubMed 32703590Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06.003. Epub 2019 Sep 25.
PubMed 31563688Murai T, Yonetsu T, Kanaji Y, Usui E, Hoshino M, Hada M, Hamaya R, Kanno Y, Lee T, Kakuta T. Prognostic value of the index of microcirculatory resistance after percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1063-1074. doi: 10.1002/ccd.27529. Epub 2018 Feb 15.
PubMed 29446567Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.
PubMed 31648761Lee SJ, Lee SJ, Hong SJ, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee SH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Lee JY, Kim BK. Optical coherence tomography-guided stent optimization for complex coronary lesions: the OCCUPI trial. Eur Heart J. 2026 Feb 9;47(5):608-621. doi: 10.1093/eurheartj/ehaf884.
PubMed 41259082Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
PubMed 37634149Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.1056/NEJMoa2305861. Epub 2023 Aug 27.
PubMed 37634188Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Angiography-Derived Physiological Indices in Patients Undergoing OCT-Guided Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07511231
- Acronym / sponsor ID
- ADOPT-PCI / BeijingAnzhen3
- Keywords
- Optical Coherence Tomography, OCT-guided PCI, Angiography-derived Fractional Flow Reserve, Angiography-derived Index of Microcirculatory Resistance, Pullback Pressure Gradient, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 6 Apr 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.
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:
- To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up.
- To evaluate the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR when added to models incorporating baseline clinical characteristics and OCT-derived anatomical parameters for predicting MACE.
- To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: OCT-guided PCIPatients 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. |
| Prospective cohort | – | Procedure: OCT-guided PCIPatients 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
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 |
|---|---|---|
| OCT-guided PCINot 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. | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: Up to 24 months after the index PCI
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.
6 secondary outcomes
All-cause death
Time frame: Up to 24 months after the index PCI
Spontaneous target-vessel myocardial infarction
Time frame: Up to 24 months after the index PCI
Ischemia-driven target-vessel revascularization
Time frame: Up to 24 months after the index PCI
Hospitalization for unstable angina
Time frame: Up to 24 months after the index PCI
Hospitalization for heart failure
Time frame: Up to 24 months after the index PCI
Seattle Angina Questionnaire (SAQ) score
Time frame: At 6, 12, and 24 months after the index PCI
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 6 Apr 2026.
- Results publication: PubMed 41137850Ikeda K, Mizukami T, Sakai K, Bouisset F, Sonck J, Wilgenhof A, Matsuo H, Shinke T, Ando H, Hada M, Ko B, Biscaglia S, Rivero F, Engstrom T, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Keulards D, Zimmermann FM, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson TW, Munhoz D, Amano T, Perera D, Jeremias A, Ali ZA, Kubo T, Satomi K, Tanaka N, De Bruyne B, Johnson NP, Collet C. Impact of Pullback Pressure Gradient on Clinical Outcomes after Percutaneous Coronary Interventions. Circ Cardiovasc Interv. 2025 Dec;18(12):e016022. doi: 10.1161/CIRCINTERVENTIONS.125.016022. Epub 2025 Oct 25.
- Results publication: PubMed 40406943Johnson TW, Bergmark BA, Croce K, Pellegrini D, Maehara A, Gori T, Pinilla-Echeverri N, Wollmuth J, Gonzalo N, Kao HL, Guagliumi G, Phalakornkule K, Ediebah D, McNutt J, Chiu WC, Op den Buijs J, Buccola J, Landmesser U, Ali Z, Stone GW, Jeremias A. Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy. J Am Coll Cardiol. 2025 Jul 15;86(2):93-102. doi: 10.1016/j.jacc.2025.05.019. Epub 2025 May 22.
- Results publication: PubMed 38685980Wang D, Li X, Feng W, Zhou H, Peng W, Wang X. Diagnostic and prognostic value of angiography-derived index of microvascular resistance: a systematic review and meta-analysis. Front Cardiovasc Med. 2024 Apr 15;11:1360648. doi: 10.3389/fcvm.2024.1360648. eCollection 2024.
- Results publication: PubMed 32703590Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.
- Results publication: PubMed 31563688Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06.003. Epub 2019 Sep 25.
- Results publication: PubMed 29446567Murai T, Yonetsu T, Kanaji Y, Usui E, Hoshino M, Hada M, Hamaya R, Kanno Y, Lee T, Kakuta T. Prognostic value of the index of microcirculatory resistance after percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1063-1074. doi: 10.1002/ccd.27529. Epub 2018 Feb 15.
- Results publication: PubMed 31648761Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.
- Results publication: PubMed 41259082Lee SJ, Lee SJ, Hong SJ, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee SH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Lee JY, Kim BK. Optical coherence tomography-guided stent optimization for complex coronary lesions: the OCCUPI trial. Eur Heart J. 2026 Feb 9;47(5):608-621. doi: 10.1093/eurheartj/ehaf884.
- Results publication: PubMed 37634149Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
- Results publication: PubMed 37634188Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.1056/NEJMoa2305861. Epub 2023 Aug 27.
- Results publication: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Individual participant dataSharing planned: No. Due to patient privacy and ethical restrictions
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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.
min zhang principal investigator
Beijing Anzhen Hospital
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 Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Beijing Anzhen Hospital 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?
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: opening soon, as of the sponsor's last update on 6 Apr 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?
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 Chenchen Tu, Doctor (+8615201648899, tcc2033@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: Up to 24 months after the index 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 NCT07511231, which also lists 11 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 6 Apr 2026.