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Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI (CHART-PATTERN)

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ClinicalTrials.gov Identifier: NCT04665466
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
China National Center for Cardiovascular Diseases
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Ischemia Atherosclerosis Percutaneous Coronary Intervention Device: Quantitative Flow Ratio derived PPG

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 1003 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : November 2013
Actual Primary Completion Date : February 2021
Actual Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
QFR≤0.80 vessels with PCI strategy and low PPG index
 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.
Group B
QFR≤0.80 vessels with PCI strategy and high PPG index
 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.
Group C
QFR≤0.80 vessels with conservative strategy
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Vessel-oriented composite outcome [ Time Frame: at 2 years from index procedure ]
    Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.


Secondary Outcome Measures :
  1. Cardiac death or vessel-related MI [ Time Frame: at 2 years from index procedure ]
    Cardiac death or vessel-related MI

  2. Vessel-related MI [ Time Frame: at 2 years from index procedure ]
    Vessel-related MI

  3. Cardiac death [ Time Frame: at 2 years from index procedure ]
    Cardiac death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1003 patients with 1444 target vessels with measurable QFR≤ 0.80 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).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665466


Locations
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China
180 Fenglin Road
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
China National Center for Cardiovascular Diseases
Investigators
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Study Chair: Junbo Ge, Professor Fudan University
Principal Investigator: Bo Xu, MBBS Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
More Information
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Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04665466    
Other Study ID Numbers: ZS-20201206
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes