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

NCT ID: NCT04665466

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1003 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2021-02-28

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.

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.

Conditions

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

Study Design

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

Study Groups

Group A

QFR≤0.80 vessels with PCI strategy and low PPG index

Quantitative Flow Ratio derived PPG

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.

Group B

QFR≤0.80 vessels with PCI strategy and high PPG index

Quantitative Flow Ratio derived PPG

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.

Group C

QFR≤0.80 vessels with conservative strategy

Quantitative Flow Ratio derived PPG

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

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

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

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

Locations

180 Fenglin Road

Shanghai, , China

Countries

China

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)

Other Identifiers

ZS-20201206

Identifier Type: -

Identifier Source: org_study_id