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

NCT04665466 | Completed

• 1 other identifier: ZS-20201206
• Study Type: observational
• Target: 1,003
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cardiac death or vessel-related MI

  at 2 years from index procedure

• Vessel-related MI

  at 2 years from index procedure

• Cardiac death

  at 2 years from index procedure

Study Arms (3)

Group A

QFR≤0.80 vessels with PCI strategy and low PPG index

Device: Quantitative Flow Ratio derived PPG

Group B

QFR≤0.80 vessels with PCI strategy and high PPG index

Device: Quantitative Flow Ratio derived PPG

Group C

QFR≤0.80 vessels with conservative strategy

Device: Quantitative Flow Ratio derived PPG

Interventions

Quantitative Flow Ratio derived PPG 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 A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• China National Center for Cardiovascular Diseases: collaborator

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Related 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.

  PMID: 27173037 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  STUDY CHAIR

• Bo Xu, MBBS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: November 1, 2013
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)