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Recruiting
NCT05658952
Physiology Optimized Versus Angio-guided PCI
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 300
Sponsor: University Hospital of Ferrara
Location: Italy
Summary
Angiography-derived Fractional Flow Reserve (FFR) Virtual Percutaneous Coronary Intervention (PCI) plan is superior to conventional angiography-guided PCI in obtaining a good final physiology result, which is, in turn, associated with better prognosis.
This has been demonstrated in a population with a relatively low lesion complexity.Therefore, whether angiography-based FFR virtual PCI could guarantee the same results in some complex anatomical settings (tortuous or calcific vessels, tandem or bifurcation lesions) is not known, also given the inherent limitations of the 3Dimensional (3D)-reconstruction.The ability of invasive FFR to achieve the same result if compared to angiography-guided PCI has been questioned by recent studies.
Recent technological developments, namely the design of pressure wire microcatheters may allow an easier handling of the procedural planning and guidance.The rationale of the AQVA II study is to test whether a longitudinal FFR-based virtual PCI either angio- or microcatheter- derived is able to improve the post-PCI physiology value if compared to angio-guided PCI in complex and high-risk indicated procedures (CHIP).
Eligibility Criteria
Inclusion Criteria:Indication to PCI for either acute or chronic coronary syndromeSigned informed consentAt least one of the following CHIP lesion characteristic:Long lesion (>28 mm);Tandem lesions;Severe calcifications;Severe tortuosity;True bifurcation lesions: involving a significant (> 50%) diameter stenosis both in the main vessel and side branch (i.e.
MEDINA 1,1,1; 1,0,1; or 0,1,1) and with a relevant side branch, namely ≥2.00 mm;In-stent restenosis (ISR).Left main stem disease.Exclusion Criteria:Planned surgical revascularizationPrior Coronary Artery Bypass Graft (CABG) SurgeryCulprit lesion of STEMI or NSTEMIRevascularization of a chronic total occlusionNon-cardiovascular co-morbidity reducing life expectancy to < 1 yearAny factor precluding 1-year follow-up
Source: ClinicalTrials.gov (NCT05658952). StuddyBuddy aggregates publicly available trial information.