Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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