International Post PCI FFR Registry

NCT ID: NCT04012281

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-17
• Study Completion Date: 2019-03-28

Brief Summary

The prognostic factors after a percutaneous coronary intervention (PCI) have not been comprehensively investigated. The investigators sought to develop a risk model to predict future clinical events after PCI using contemporary coronary stents.

Detailed Description

Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. However, the risk of future clinical events still remain high and about 10% of patients experienced further cardiovascular events after PCI. There are several factors that are associated with these poor outcomes. Known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI and presentation with the acute coronary syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge dissection, the number of the used stent and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI and low post PCI FFR value was associated with procedural factors. However, all of these risk factors were identified in individual studies there have been no studies that comprehensively evaluated these risk factors. Therefore, the investigators sought to investigate the risk predictors of future clinical events in patients after PCI and develop a risk model, incorporating clinical, angiographic, and physiologic factors, to predict the clinical events after PCI using contemporary coronary stents.

The study population of this study is from the International Post PCI FFR Registry, which included 4 different registries from Korea, China, and Japan. All patients in this registry are available with clinical, angiographic and physiologic data and used 2nd generation drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and enrolled a total of 835 patients available post PCI FFR value after angiographically successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438) enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them, 266 patients with 337 vessels who measure post PCI FFR values were included in this international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of 1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1 hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to evaluate the prognostic value of post PCI FFR on patients' future outcome. For this international registry, 780 patients with 794 vessels from Nanjing First Hospital in China, who were available with whole clinical, angiographic and physiologic data, were included in this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki, Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR measurement.

Conditions

Coronary Disease

Study Design

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

Study Groups

Post PCI state

The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured fractional flow reserve after PCI

Percutaneous coronary intervention

Intervention Type: DEVICE

PCI was performed using 2nd generation DES

Interventions

Percutaneous coronary intervention

PCI was performed using 2nd generation DES

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who underwent PCI and post-PCI FFR measurements after angiographically successful stent implantation (residual stenosis < 20% by visual estimation)
• Patients who provided informed consent

Exclusion Criteria

• Post-PCI TIMI flow of < 3
• Depressed left ventricular systolic function (ejection fraction < 30%)
• Culprit lesion for acute coronary syndrome
• Graft vessel
• Collateral feeder
• In-stent stenosis
• Primary myocardial or valvular heart disease
• Patients with life expectancy < 2 years.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Tsuchiura Kyodo General Hospital

OTHER

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: collaborator

Ulsan University Hospital

OTHER

Sponsor Role: collaborator

Busan Veterans General Hospital

UNKNOWN

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Sejong General Hospital

OTHER

Sponsor Role: collaborator

Tokyo Medical University

OTHER

Sponsor Role: collaborator

Gifu Heart Center

OTHER

Sponsor Role: collaborator

Japanese Red Cross Kyoto Daini Hospital

UNKNOWN

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bon-Kwon Koo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bon-Kwon Koo, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Joon Hyung Doh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Shao-Liang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University

Tsunekazu Kakuta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tsuchiura Kyodo General Hospital

Joo Myung Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

References

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Other Identifiers

1906-152-1044

Identifier Type: -

Identifier Source: org_study_id