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

RecruitingNAAges 18 Years - anyAllFundación EPIC
NCT06273293 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ass

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Fractional Flow Reserve
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Where

4 sites
Hospital Universitario San Juan de Alicante
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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