RecruitingNot ApplicableNCT06273293

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

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients


Sponsor

Fundación EPIC

Enrollment

150 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DIAGNOSTIC_TESTFractional Flow Reserve

Agreement measurements between the different post-ICP functional values (cFFR+NTG and FFR) will be performed at the end of the intervention on the treated vessels. The study protocol consists of 4 sequential steps (separated by at least 30 sec): 1. Determination of FFR with contrast and NTG: cFFR +NTG will be calculated with the lowest ratio after the infusion of 0.2 mg bolus of intracoronary NTG and pushed with contrast. 2. Determination of distal pressure between basal aortic pressure: The Pd/Pa will be obtained after about 30-60 seconds of the NTG bolus in step 1. 3. Determination of the diastolic dPR index: the average value (2-3 determinations). 4. Determination of fractional flow reserve with adenosine: The FFR will be obtained after continuous peripheral venous infusion with adenosine or with intracoronary boluses according to the protocol of each center.


Locations(4)

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

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NCT06273293


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