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Search / Trial NCT06273293

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

Launched by FUNDACIÓN EPIC · Feb 21, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Percutaneous Coronary Intervention (Pci) Fractional Flow Reserve

ClinConnect Summary

The PROMETEUS TRIAL is studying a new method to evaluate heart arteries in patients with coronary disease who have multiple affected vessels. The trial focuses on a technique called cFFR-NTG, which helps doctors measure blood flow in the heart without using a medication called adenosine, which can sometimes cause side effects. Researchers want to see how well this new method compares to traditional measurements in predicting heart-related problems after treatment and how it can improve care for patients with more than one blocked artery.

To participate in this study, individuals must be over 18 years old and have significant blockages in at least two major heart arteries. Participants should have a plan for a specific heart procedure and must agree to take part by signing a consent form. Those who have serious health issues, are pregnant, or have negative reactions to adenosine will not be eligible. If you join the trial, you will undergo tests to help doctors better understand your heart's condition and how it relates to your future health.

Gender

ALL

Eligibility criteria

  • 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.

About Fundación Epic

Fundación Epic is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a robust focus on improving patient outcomes, the foundation collaborates with healthcare professionals, research institutions, and industry partners to design and implement clinical studies across various therapeutic areas. Fundación Epic emphasizes ethical standards, scientific integrity, and patient safety, ensuring that all trials are conducted with the utmost care and rigor. Through its commitment to fostering cutting-edge research and promoting collaboration, Fundación Epic aims to contribute significantly to the development of new therapies and improve healthcare solutions globally.

Locations

Sevilla, , Spain

Badajoz, , Spain

Huelva, , Spain

Alicante, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported