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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Quantitative Flow Ratio derived PPG and dQFR/ds

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.

• Study Type: Observational
• Enrollment (Anticipated): 1607

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All vessels with measurable post-PCI QFR and with available post-PCI QFR virtual pullback curves were included

Description

Inclusion Criteria:

• Patients with at least one vessel with measurable post-PCI QFR
• PPG index can be calculated from virtual QFR pullback curve
• dQFR/ds 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Predominant focal residual disease without major gradient	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)
Group 2; Predominant focal residual disease with major gradient	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)
Group 3; Predominant diffuse residual disease without major gradient	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)
Group 4; Predominant diffuse residual disease with major gradient	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Bo Xu, MBBS, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available. Erratum In: JACC Cardiovasc Interv. 2021 Sep 13;14(17):1963.
• Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.
• Dai N, Zhang R, Hu N, Guan C, Zou T, Qiao Z, Zhang M, Duan S, Xie L, Dou K, Zhang Y, Xu B, Ge J. Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):E12-E21. doi: 10.1002/ccd.29983. Epub 2021 Oct 15.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ZS-20211112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No