NCT05125107

PrOgnostic imPlicaTIons of 2-diMensIonal Patterns for Residual Disease After Stenting CharacteriZEd by Quantitative Flow Ratio Pullback Curve Analysis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,607 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the prognostic values of 2-dimensional residual disease patterns determined by quantitative flow ratio (QFR) pullbacks after stent implantation.

Detailed description

Prognostic value of post-percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI) physiology assessment has been confirmed. The rationale for measuring post-PCI physiologic outcome is that it could implicate the residual risk of suboptimal stenting in addition to residual diffuse coronary artery disease after PCI Nevertheless, it should be noted that both post-PCI physiologic indices such as ,fractional flow reserve (FFR) and QFR, are measured at the distal of the interrogated vessel and reflect the cumulative residual disease burdens, defining the residual disease patterns might have additional role in exploring the underlying mechanisms for suboptimal post-PCI physiologic results, thus providing the opportunities for functional optimization with subsequent interventions accordingly to improve immediate functional results, long-term outcomes may be positively affected. Concept of physiologic 2-dimensional disease patterns according to both physiologic distribution (predominant focal versus diffuse disease) and local severity (presence versus absence of major gradient) of coronary atherosclerosis before PCI was proposed and could be derived from virtual QFR pullback curve. Nevertheless, the prognostic value of the 2-dimensional residual disease patterns after PCI has not been studied yet. The CHART-OPTIMIZE study aims to investigate the clinical implications of physiologic 2-dimensional residual disease patterns after stenting.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Quantitative Flow Ratio derived PPG and dQFR/ds	From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as: PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2 Physiologic local severity of coronary atherosclerosis was assessed by instantaneous QFR gradient per unit length (dQFR/ds)

Timeline

• Start date: 2021-11-15
• Primary completion: 2021-12-30
• Completion: 2022-03-30
• First posted: 2021-11-18
• Last updated: 2021-11-18