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

NCT06273293 | Recruiting DMC

• 1 other identifier: EPIC35-PROMETEUS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Coronary Disease

Keywords

Percutaneous Coronary Intervention (PCI); Fractional Flow Reserve

Outcome Measures

Primary Outcomes (2)

• Agreement between cFFR+NTG and FFR

  To evaluate the agreement between cFFR+NTG and FFR after successful angiographic revascularization of lesions in multivessel patients.

  Index Procedure

• SAFETY: MACE

  To evaluate the safety associated with performing PCI in multivessel patients with a pre- and post-PCI functional study in terms of MACE at 12 months that includes: Cardiovascular death, Acute myocardial infarction of the lesion treated/functionally evaluated, Need for revascularization of the treated/functionally evaluated lesion.

  12 months

Secondary Outcomes (9)

• Agreement between Pd/Pa or dPR and FFR

  Index Procedure

• Cut-off point for cFFR+NTG post-ICP

  Index Procedure

• Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI

  Index Procedure

• Cardiac death

  12 months

• Cardiovascular death

  12 months

Study Arms (1)

Percutaneous coronary intervention (PCI) and guide wire post PCI in multivessel patients

OTHER

Diagnostic Test: Fractional Flow Reserve

Interventions

Fractional Flow Reserve DIAGNOSTIC_TEST

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.

Percutaneous coronary intervention (PCI) and guide wire post PCI in multivessel patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (4)

Hospital Universitario San Juan de Alicante

Alicante, 03550, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Related Publications (5)

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 BACKGROUND

• van Nunen LX, Zimmermann FM, Tonino PA, Barbato E, Baumbach A, Engstrom T, Klauss V, MacCarthy PA, Manoharan G, Oldroyd KG, Ver Lee PN, Van't Veer M, Fearon WF, De Bruyne B, Pijls NH; FAME Study Investigators. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1853-60. doi: 10.1016/S0140-6736(15)00057-4. Epub 2015 Aug 30.

  PMID: 26333474 BACKGROUND

• Gutierrez-Barrios A, Noval-Morillas I, Camacho-Freire S, Puche JE, Gheorghe L, Silva E, Alarcon-Lastra I, Canadas-Pruano D, Gomez-Menchero A, Calle-Perez G, Diaz-Fernandez JF, Vazquez-Garcia R. Contrast FFR plus intracoronary injection of nitro-glycerine accurately predicts FFR for coronary stenosis functional assessment. Minerva Cardiol Angiol. 2021 Aug;69(4):449-457. doi: 10.23736/S2724-5683.20.05354-2. Epub 2020 Dec 1.

  PMID: 33258564 BACKGROUND

• Patel MR, Jeremias A, Maehara A, Matsumura M, Zhang Z, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp ASP, Ali ZA, Mintz G, Davies J, Stone GW. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovasc Interv. 2022 Jan 10;15(1):52-61. doi: 10.1016/j.jcin.2021.09.042.

  PMID: 34991824 BACKGROUND

• Thakur U, Khav N, Comella A, Michail M, Ihdayhid AR, Poon E, Nicholls SJ, Ko B, Brown AJ. Fractional Flow Reserve following Percutaneous Coronary Intervention. J Interv Cardiol. 2020 Jun 5;2020:7467943. doi: 10.1155/2020/7467943. eCollection 2020.

  PMID: 32565755 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

SANTIAGO J CAMACHO FREIRE, MD, PhD

CONTACT

0034677981941; hemodinamica.cardiologia.huelva@gmail.com

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ES (4)