Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI

Coronary Artery Disease Clinical Trial

— CHART-PATTERN  

Official title:

Combined AngiograpHy-derived Fractional Flow Reserve and Pullback Pressure Gradient Assessment to Better Discriminate Coronary ARTery Disease PAtients Benefiting From PercuTaneous Coronary InTERventioN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665466
• Other study ID #: ZS-20201206
• Status: Completed
• Start date: November 2013
• Est. completion date: February 2021

Study information

• Verified date: March 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.

In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.

Description:

Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.

In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.

The study cohort is derived from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275). In this cohort, vessels with measurable QFR≤ 0.80 will be included. According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen, the included vessels were divided into three groups(vessels with PCI strategy and low PPG index (group A), vessels with PCI strategy with high PPG index (group B) and vessels with conservative strategy (group C)) and 2-year clinical outcomes for each group will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with at least one vessel with measurable QFR= 0.80;

• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (1)

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