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

Coronary Artery Disease Clinical Trial

— CHART-OPTIMIZE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05125107
• Other study ID #: ZS-20211112
• Status: Not yet recruiting
• Start date: November 15, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Neng Dai, MD
• Phone: +8613701997266
• Email: niceday1987[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1607
• Est. completion date: March 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Chinese Academy of Medical Sciences, Fuwai Hospital

References & Publications (3)

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. Erratum in: JACC Cardiovasc Interv. 2021 Sep 13;14(17):1963. — View Citation

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. 2021 Oct 15. doi: 10.1002/ccd.29983. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac death or vessel-related MI	Cardiac death or vessel-related MI	at 2 years from index procedure
Secondary	Vessel-related MI	Vessel-related MI	at 2 years from index procedure
Secondary	Cardiac death	Cardiac death	at 2 years from index procedure
Secondary	Ischemia-driven target vessel revascularization	Ischemia-driven target vessel revascularization	at 2 years from index procedure