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

Recruiting now · Not applicable

Conditions studied: Coronary Disease

In brief

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.

Key facts

Study ID: NCT06273293
Run by: Fundación EPIC
People needed: 150
Starts: 2024-05-31
Expected to finish: 2027-01-20
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients >18 years old and,
Patients with multivessel coronary artery disease (multivessel coronary artery disease will be considered the presence of significant stenosis in 2 or more first or second order vessels greater than 1.5 mm in diameter with an angiographic reduction of their diameter ≥50% by visual estimation) subsidiary of percutaneous coronary revascularization in at least one of them and,
Use of Navvus pressure microcatheter both for functional diagnosis and for post-PCI evaluation of the different vessels and,
Patients who have signed the Informed Consent.

You may not qualify if…

Patients with intolerance or contraindication to adenosine.
Hemodynamically unstable patients, acute phase of a STEACS.
Patient with significant comorbidity with limited life expectancy.
Patients with the patient's express refusal to participate in the study.
Pregnant or breastfeeding female patients.

Where it is running

Hospital Universitario San Juan de Alicante — Alicante, Spain (enrolling)
Hospital Universitario de Badajoz — Badajoz, Spain (enrolling)
Hospital Universitario Juan Ramón Jiménez — Huelva, Spain (enrolling)
Hospital Universitario Virgen del Rocío — Seville, Spain (enrolling)

Full record on ClinicalTrials.gov

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