Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06273293

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

Led by Fundación EPIC · Updated on 2026-02-17

150

Participants Needed

4

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions. In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI. The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up.

CONDITIONS

Official Title

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Patients with multivessel coronary artery disease defined by significant narrowing in two or more vessels at least 1.5 mm in diameter with at least 50% diameter reduction
  • Use of Navvus pressure microcatheter for functional diagnosis and post-PCI evaluation
  • Patients who have signed the Informed Consent
Not Eligible

You will not qualify if you...

  • Patients intolerant or with contraindications to adenosine
  • Hemodynamically unstable patients or in the acute phase of STEACS
  • Patients with serious other illnesses limiting life expectancy
  • Patients who refuse to participate in the study
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Hospital Universitario San Juan de Alicante

Alicante, Spain, 03550

Actively Recruiting

2

Hospital Universitario de Badajoz

Badajoz, Spain, 06080

Actively Recruiting

3

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain, 21005

Actively Recruiting

4

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

Actively Recruiting

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Research Team

S

SANTIAGO J CAMACHO FREIRE, MD, PhD

CONTACT

F

FUNDACION EPIC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL) | DecenTrialz