NCT05104580

PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,395 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).

Detailed description

Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results. QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now. The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Quantitative Flow Ratio derived PPG	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.

Timeline

• Start date: 2021-10-30
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2021-11-03
• Last updated: 2021-11-03