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

NCT ID: NCT05125107

Last Updated: 2021-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1607 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-03-30

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Predominant focal residual disease without major gradient

Quantitative Flow Ratio derived PPG and dQFR/ds

Intervention Type: DEVICE

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

Quantitative Flow Ratio derived PPG and dQFR/ds

Intervention Type: DEVICE

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

Quantitative Flow Ratio derived PPG and dQFR/ds

Intervention Type: DEVICE

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

Quantitative Flow Ratio derived PPG and dQFR/ds

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo Ge, Professor

Role: STUDY_CHAIR

Fudan University

Bo Xu, MBBS

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Central Contacts

Neng Dai, MD

Role: CONTACT

Phone: +8613701997266

Email: niceday1987@hotmail.com

References

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.

Reference Type: BACKGROUND

PMID: 27173037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33541549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34652068 (View on PubMed)

Other Identifiers

ZS-20211112

Identifier Type: -

Identifier Source: org_study_id