CompletedNCT04975425Disengage@RestUpdated Feb 23, 2024

Effects of Guiding Catheter on FFR and NHPR for the Assessment of Coronary Artery Stenoses (Disengage@Rest)

An observational study in Coronary Artery Disease, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Federico II University · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years and older
Sex: All

Study summary

The DISENGAGE@rest study is a prospective registry carried out at Federico II University of Naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both FFR and non-hyperaemic pressure ratios values (such as Pd/Pa and the Resting Full-cycle Ratio -RFR), as well as the corresponding clinical impact on decision-making strategies. Consecutive patients with at least one intermediate stenosis (40%-90% by visual estimation) in any of the 3 main coronary arteries will be included.

Conditions studied

Coronary Artery Disease

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Keywords

Fractional Flow Reserve
Resting Full-Cycle Ratio

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 200 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patient > 18 years old with coronary artery disease and indication to perform functional assessment

Inclusion criteria

Age > 18 years;
Patients provides informed consent;
Documented coronary artery disease:
chronic coronary syndromes
acute coronary syndromes presenting with at least one stenosis with indication for invasive functional assessment.

Exclusion criteria

Exclusion Criteria:

Patients unable to provide informed consent;
Pregnant women;
Any contraindication to perform angiographic study or functional evaluation with pressure wire;
Patients with aorto-ostial stenosis
Target vessel diameter \< 2mm

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 200 participants (actual)
Patient registry: No

Interventions

Diagnostic testFractional Flow Reserve
Comparison between FFR and NHPR before and after guiding catheter disengagement
Also known as: RFR, Pd/Pa

What researchers measure

Primary outcomes

Differences between FFR before and after guiding catheter disengagement
Evaluate the influence of the guiding catheter engagement within the coronary ostium on FFR values.
Time frame: 10 minutes
1. Differences between NHPR before and after guiding catheter disengagement
Evaluate the influence of the guiding catheter engagement within the coronary ostium on NHPR values
Time frame: 10 minutes

Study locations

1 site

Federico II University of Naples
Naples, 80131, Italy

References and documents

Publications

Ben Ahmed H, Bouzouita K, Hamdi I, Boussaid H, Mokaddem A, Ben Ameur Y, Boujnah MR. [Limits of quantitative coronary angiography (QCA) in intermediate stenosis measuring: a correlation and concordance study with intravascular ultrasound (IVUS)]. Tunis Med. 2014 Jun;92(6):373-8. French. PubMed 25741837 ↗
Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973. PubMed 25323250 ↗
Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18. PubMed 24644308 ↗
Adjedj J, De Bruyne B, Flore V, Di Gioia G, Ferrara A, Pellicano M, Toth GG, Bartunek J, Vanderheyden M, Heyndrickx GR, Wijns W, Barbato E. Significance of Intermediate Values of Fractional Flow Reserve in Patients With Coronary Artery Disease. Circulation. 2016 Feb 2;133(5):502-8. doi: 10.1161/CIRCULATIONAHA.115.018747. Epub 2016 Jan 5. PubMed 26733607 ↗
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. PubMed 19144937 ↗
De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465. PubMed 25176289 ↗
Adjedj J, Toth GG, Johnson NP, Pellicano M, Ferrara A, Flore V, Di Gioia G, Barbato E, Muller O, De Bruyne B. Intracoronary Adenosine: Dose-Response Relationship With Hyperemia. JACC Cardiovasc Interv. 2015 Sep;8(11):1422-1430. doi: 10.1016/j.jcin.2015.04.028. PubMed 26404193 ↗
Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201. PubMed 449946 ↗
van de Hoef TP, Lee JM, Echavarria-Pinto M, Koo BK, Matsuo H, Patel MR, Davies JE, Escaned J, Piek JJ. Non-hyperaemic coronary pressure measurements to guide coronary interventions. Nat Rev Cardiol. 2020 Oct;17(10):629-640. doi: 10.1038/s41569-020-0374-z. Epub 2020 May 14. PubMed 32409779 ↗
Jeremias A, Maehara A, Genereux P, Asrress KN, Berry C, De Bruyne B, Davies JE, Escaned J, Fearon WF, Gould KL, Johnson NP, Kirtane AJ, Koo BK, Marques KM, Nijjer S, Oldroyd KG, Petraco R, Piek JJ, Pijls NH, Redwood S, Siebes M, Spaan JAE, van 't Veer M, Mintz GS, Stone GW. Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study. J Am Coll Cardiol. 2014 Apr 8;63(13):1253-1261. doi: 10.1016/j.jacc.2013.09.060. Epub 2013 Nov 6. PubMed 24211503 ↗
Svanerud J, Ahn JM, Jeremias A, van 't Veer M, Gore A, Maehara A, Crowley A, Pijls NHJ, De Bruyne B, Johnson NP, Hennigan B, Watkins S, Berry C, Oldroyd KG, Park SJ, Ali ZA. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018 Sep 20;14(7):806-814. doi: 10.4244/EIJ-D-18-00342. PubMed 29790478 ↗
Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5. PubMed 20516504 ↗
van Nunen LX, Zimmermann FM, Tonino PA, Barbato E, Baumbach A, Engstrom T, Klauss V, MacCarthy PA, Manoharan G, Oldroyd KG, Ver Lee PN, Van't Veer M, Fearon WF, De Bruyne B, Pijls NH; FAME Study Investigators. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1853-60. doi: 10.1016/S0140-6736(15)00057-4. Epub 2015 Aug 30. PubMed 26333474 ↗
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22. PubMed 29785878 ↗
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242. doi: 10.1093/eurheartj/ehz825. PubMed 31504439 ↗
Toth GG, Johnson NP, Jeremias A, Pellicano M, Vranckx P, Fearon WF, Barbato E, Kern MJ, Pijls NH, De Bruyne B. Standardization of Fractional Flow Reserve Measurements. J Am Coll Cardiol. 2016 Aug 16;68(7):742-53. doi: 10.1016/j.jacc.2016.05.067. PubMed 27515335 ↗
Pellicano M, Ciccarelli G, Xaplanteris P, Di Gioia G, Milkas A, Colaiori I, Heyse A, Van Durme F, Vanderheyden M, Bartunek J, De Bruyne B, Barbato E. DISENGAGE Registry. Circ Cardiovasc Interv. 2020 Nov;13(11):e008640. doi: 10.1161/CIRCINTERVENTIONS.119.008640. Epub 2020 Nov 2. PubMed 33131299 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04975425
Lead sponsor: Federico II University
Responsible party: Giovanni Esposito (Full Professor of Cardiology, Federico II University) — Principal investigator
First posted: Jul 23, 2021
Start date: Jul 1, 2021
Primary completion: Jul 30, 2022
Completion: Jul 30, 2022
Last update: Feb 23, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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