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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Quantitative Flow Ratio derived PPG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with at least one vessel with measurable QFR PPG index can be calculated from virtual QFR pullback curve; The patient is willing to comply with specified follow-up evaluations; Patients who agree to accept the follow-up visits. Exclusion Criteria: Culprit vessels for ACS myocardial infarction; Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure; Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year); Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated; Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study; Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>High pre-PCI PPG index and high post-PCI QFR | Device: Quantitative Flow Ratio derived PPG<br>* 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.<br>|
| Group 2<br>Low pre-PCI PPG index and high post-PCI QFR | Device: Quantitative Flow Ratio derived PPG<br>* 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.<br>|
| Group 3<br>Low post-PCI QFR regardless of pre-PCI PPG index | Device: Quantitative Flow Ratio derived PPG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel-oriented composite outcome | Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death. | at 2 years from index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death or vessel-related MI | Cardiac death or vessel-related MI | at 2 years from index procedure | 
| Vessel-related MI | Vessel-related MI | at 2 years from index procedure | 
| Cardiac death | Cardiac death | at 2 years from index procedure | 
| Ischemia-driven target vessel revascularization | Ischemia-driven target vessel revascularization | at 2 years from index procedure |