protocolSection identificationModule nctId: NCT06280638, orgStudyIdInfo id: 2023-2095, briefTitle: CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS), acronym: CT-COMPASS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90)., conditionsModule conditions: Percutaneous Coronary Intervention, conditions: Coronary Physiology, conditions: Computed Tomography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Virtual stent-guided incremental optimization strategy (VIOS), interventions name: Standard angiographic strategy, outcomesModule primaryOutcomes measure: The proportion of patients with a final post-PCI FFR result ≥0.90, secondaryOutcomes measure: The proportion of patients with final post-PCI FFR ≤0.80, secondaryOutcomes measure: The rate of target vessel failure (TVF) and its component features at 6 months., secondaryOutcomes measure: The rate of target vessel failure (TVF) and its component features at 1 year., secondaryOutcomes measure: Change from baseline in self-reported Health-related quality of life evaluation at 6 months., secondaryOutcomes measure: Change from baseline in self-reported Health-related quality of life evaluation at 1 year., secondaryOutcomes measure: Change from baseline in self-reported Angina status evaluation at 6 months., secondaryOutcomes measure: Change from baseline in self-reported Angina status evaluation at 1 year., secondaryOutcomes measure: Procedure Duration, secondaryOutcomes measure: Fluoroscopy Dose, secondaryOutcomes measure: Contrast Material Dose, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, city: Beijing, state: Beijing, zip: 100037, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False