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Angiography-Derived Physiological Indices for Outcome Prediction in Patients Undergoing OCT-Guided PCI

NCT07511231 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2026-04-06

No results posted yet for this study

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 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:

1. To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up.
2. 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.
3. To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.

Conditions

  • Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Interventions

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.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • min zhang · Beijing Anzhen Hospital

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2029-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511231 on ClinicalTrials.gov