Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

NCT ID: NCT01873560

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

Brief Summary

Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.

Detailed Description

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.

Conditions

Coronary Disease

Study Design

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

Study Groups

FFRpost

High FFRpost group and low FFRpost group were defined according to the optimal cut-off value for predicting clinical outcome.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure
• patient who provide informed consent

Exclusion Criteria

• culprit vessel of acute coronary syndrome
• failed achieving TIMI 3 flow at the end of PCI
• left ventricular ejection fraction <30%
• graft vessel
• collateral feeder
• in-stent stenosis
• primary myocardial or valvular heart disease
• in patient whose life expectancy less than 2 years
• visible thrombus of target vessel segment

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University 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: lead

Responsible Party

Joon Hyung Doh

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joon Hyung Doh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje Univesity Ilsan Paik Hospital

Bon-Kwon Koo

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

Pijls NH, Klauss V, Siebert U, Powers E, Takazawa K, Fearon WF, Escaned J, Tsurumi Y, Akasaka T, Samady H, De Bruyne B; Fractional Flow Reserve (FFR) Post-Stent Registry Investigators. Coronary pressure measurement after stenting predicts adverse events at follow-up: a multicenter registry. Circulation. 2002 Jun 25;105(25):2950-4. doi: 10.1161/01.cir.0000020547.92091.76.

Reference Type: BACKGROUND

PMID: 12081986 (View on PubMed)

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

Reference Type: BACKGROUND

PMID: 19144937 (View on PubMed)

Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.

Reference Type: BACKGROUND

PMID: 21481828 (View on PubMed)

Samady H, McDaniel M, Veledar E, De Bruyne B, Pijls NH, Fearon WF, Vaccarino V. Baseline fractional flow reserve and stent diameter predict optimal post-stent fractional flow reserve and major adverse cardiac events after bare-metal stent deployment. JACC Cardiovasc Interv. 2009 Apr;2(4):357-63. doi: 10.1016/j.jcin.2009.01.008.

Reference Type: BACKGROUND

PMID: 19463450 (View on PubMed)

Lee HJ, Mejia-Renteria H, Escaned J, Doh JH, Lee JM, Hwang D, Yuasa S, Choi KH, Jang HJ, Jeon KH, Lee J, Nam CW, Shin ES, Koo BK. Prediction of functional results of percutaneous coronary interventions with virtual stenting and quantitative flow ratio. Catheter Cardiovasc Interv. 2022 Dec;100(7):1208-1217. doi: 10.1002/ccd.30451. Epub 2022 Nov 2.

Reference Type: DERIVED

PMID: 36321601 (View on PubMed)

Lee SH, Kim J, Lefieux A, Molony D, Shin D, Hwang D, Choi KH, Chang HS, Jeon KH, Lee HJ, Jang HJ, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Lee JM. Clinical and Prognostic Impact From Objective Analysis of Post-Angioplasty Fractional Flow Reserve Pullback. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1888-1900. doi: 10.1016/j.jcin.2021.07.014.

Reference Type: DERIVED

PMID: 34503739 (View on PubMed)

Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.

Reference Type: DERIVED

PMID: 34412795 (View on PubMed)

Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.

Reference Type: DERIVED

PMID: 30561367 (View on PubMed)

Lee JM, Hwang D, Choi KH, Rhee TM, Park J, Kim HY, Jung HW, Hwang JW, Lee HJ, Jang HJ, Kim SH, Song YB, Cho YK, Nam CW, Hahn JY, Shin ES, Kawase Y, Matsuo A, Tanaka N, Doh JH, Koo BK, Matsuo H. Prognostic Implications of Relative Increase and Final Fractional Flow Reserve in Patients With Stent Implantation. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2099-2109. doi: 10.1016/j.jcin.2018.07.031.

Reference Type: DERIVED

PMID: 30336814 (View on PubMed)

Other Identifiers

IB-2-1306-020

Identifier Type: -

Identifier Source: org_study_id