Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

NCT01873560 | Completed DMC

• 1 other identifier: IB-2-1306-020
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Disease

Keywords

fractional flow reserve; drug eluting stent; coronary atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Target-vessel failure

  During two-year follow-up period, target-vessel failure (composite of cardiac death, target-vessel related myocardial infarction, and clinically-driven target vessel revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR. All clinical outcome will be reported according to the location of target vessel (LAD vs. non-LAD).

  2 years after index procedure

Secondary Outcomes (1)

• clinical, angiographic and physiologic predictors for target-vessel failure

  2 years after index procedure

Other Outcomes (1)

• Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and target vessel failure

  2 years after index procedure

Study Arms (1)

FFRpost

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

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination at the index procedure

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead
• Seoul National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Ulsan University Hospital: collaborator
• Busan Veterans General Hospital: collaborator
• Samsung Medical Center: collaborator
• Sejong General Hospital: collaborator
• Tokyo Medical University: collaborator
• Gifu Heart Center: collaborator
• Japanese Red Cross Kyoto Daini Hospital: collaborator

Study Sites (4)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (9)

• 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.

  PMID: 12081986 BACKGROUND

• 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.

  PMID: 19144937 BACKGROUND

• 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.

  PMID: 21481828 BACKGROUND

• 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.

  PMID: 19463450 BACKGROUND

• 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.

  PMID: 36321601 DERIVED

• 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.

  PMID: 34503739 DERIVED

• 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.

  PMID: 34412795 DERIVED

• 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.

  PMID: 30561367 DERIVED

• 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.

  PMID: 30336814 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Joon Hyung Doh, MD, PhD

  Inje Univesity Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

• Bon-Kwon Koo

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

KR (4)