The Utility of (Fractional Flow Reserve)FFR Before and After Successful Percutaneous Coronary Intervention

NCT04224610 | Active Not Recruiting

• 1 other identifier: 779601
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to analyze the data of patients who underwent FFR evaluation at CAVHS to evaluate the impact of PCI on coronary hemodynamics in patients with baseline ischemic FFR, the potential etiologies of suboptimal FFR post PCI, determine potential measures taken to correct persistently suboptimal FFR and PCI, and determine rate of clinical events, utility of routine Post PCI FFR strategy compared to pre PCI FFR strategy only, and evaluate the "Warranty Period" of non-ischemic FFR in different sub groups.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Impact of PCI

  • Evaluate the impact of PCI on coronary hemodynamics in patients with baseline ischemic FFR compared to final FFR

  Immediately post procedure

Secondary Outcomes (5)

• Potential etiologies of suboptimal FFR

  Immediately post procedure

• Determine potential corrective measures

  Immediately post procedure

• Determine rate of clinical events

  Immediately post procedure

• Compare post PCI FFR strategy to pre PCI FFR only

  Immediately post procedure

• Evaluate "Warranty Period"

  Through end of study, approximately 5 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that have undergone FFR at CAVHS between 3/2009 and 3/2015 will be reviewed. Comparison of baseline, angiographic, procedural and outcome variables for patients with FFR\>0.9 and \<0.9 will be done using unpaired Student's t-test for continuous variables and the chi square test( χ2 ) for categorical or dichotomous variables. Unadjusted annual event rates for those with and without FFR\>0.9 will be calculated by first estimating overall event rates for these groups through calculation of Kaplan-Meier(K-M) curves, then dividing the event rate by the mean follow-up time for each of the groups. Additionally, median pre and post FFR, (%) diameter stenosis will be calculated for patients with and without clinical outcomes.Univariate predictors of post PCI, FFR,and MACE will recorded.

You may qualify if:

• Patients that have undergone FFR at CAVHS between 3/2009 and 3/2015.

You may not qualify if:

• No FFR

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

Related Publications (8)

• Lotfi A, Jeremias A, Fearon WF, Feldman MD, Mehran R, Messenger JC, Grines CL, Dean LS, Kern MJ, Klein LW; Society of Cardiovascular Angiography and Interventions. Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: a consensus statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2014 Mar 1;83(4):509-18. doi: 10.1002/ccd.25222. Epub 2013 Nov 13. No abstract available.

  PMID: 24227282 BACKGROUND

• Hanekamp CE, Koolen JJ, Pijls NH, Michels HR, Bonnier HJ. Comparison of quantitative coronary angiography, intravascular ultrasound, and coronary pressure measurement to assess optimum stent deployment. Circulation. 1999 Mar 2;99(8):1015-21. doi: 10.1161/01.cir.99.8.1015.

  PMID: 10051294 BACKGROUND

• 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

• Fearon WF, Luna J, Samady H, Powers ER, Feldman T, Dib N, Tuzcu EM, Cleman MW, Chou TM, Cohen DJ, Ragosta M, Takagi A, Jeremias A, Fitzgerald PJ, Yeung AC, Kern MJ, Yock PG. Fractional flow reserve compared with intravascular ultrasound guidance for optimizing stent deployment. Circulation. 2001 Oct 16;104(16):1917-22. doi: 10.1161/hc4101.097539.

  PMID: 11602494 BACKGROUND

• Bech GJ, Pijls NH, De Bruyne B, Peels KH, Michels HR, Bonnier HJ, Koolen JJ. Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation. 1999 Feb 23;99(7):883-8. doi: 10.1161/01.cir.99.7.883.

  PMID: 10027810 BACKGROUND

• Klauss V, Erdin P, Rieber J, Leibig M, Stempfle HU, Konig A, Baylacher M, Theisen K, Haufe MC, Sroczynski G, Schiele T, Siebert U. Fractional flow reserve for the prediction of cardiac events after coronary stent implantation: results of a multivariate analysis. Heart. 2005 Feb;91(2):203-6. doi: 10.1136/hrt.2003.027797.

  PMID: 15657233 BACKGROUND

• Leesar MA, Satran A, Yalamanchili V, Helmy T, Abdul-Waheed M, Wongpraparut N. The impact of fractional flow reserve measurement on clinical outcomes after transradial coronary stenting. EuroIntervention. 2011 Dec;7(8):917-23. doi: 10.4244/EIJV7I8A145.

  PMID: 22157476 BACKGROUND

• Dupouy P, Gilard M, Morelle JF, Furber A, Aptecar E, Cazaux P, Slama M, Feldman LJ, Wittenberg O, Pernes JM, Huret B, Commeau P, Boschat J, Teiger E, Lafont A, Steg PG, Dubois Rande JL. Usefulness and clinical impact of a fractional flow reserve and angiographic targeted strategy for coronary artery stenting: FROST III, a multicenter prospective registry. EuroIntervention. 2005 May;1(1):85-92.

  PMID: 19758882 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Barry Uretsky, MD

  CAVHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: January 13, 2020
• Study Start: March 1, 2009
• Primary Completion: March 31, 2015
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share