Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-01 @ 12:35 PM
Study NCT ID:
NCT06273293
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053805', 'term': 'Fractional Flow Reserve, Myocardial'}], 'ancestors': [{'id': 'D003326', 'term': 'Coronary Circulation'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between cFFR+NTG and FFR', 'timeFrame': 'Index Procedure', 'description': 'To evaluate the agreement between cFFR+NTG and FFR after successful angiographic revascularization of lesions in multivessel patients.'}, {'measure': 'SAFETY: MACE', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Agreement between Pd/Pa or dPR and FFR', 'timeFrame': 'Index Procedure', 'description': 'To evaluate the agreement between Pd/Pa or dPR and FFR after successful angiographic revascularization of lesions in multivessel patients, with a cut-off point of FFR ≥0.80.'}, {'measure': 'Cut-off point for cFFR+NTG post-ICP', 'timeFrame': 'Index Procedure', 'description': 'Determine a cut-off point for cFFR+NTG post-ICP.'}, {'measure': 'Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI', 'timeFrame': 'Index Procedure', 'description': 'Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI may entail: use of intracoronary imaging techniques, post-dilation, etc.'}, {'measure': 'Cardiac death', 'timeFrame': '12 months', 'description': 'Cardiac death'}, {'measure': 'Cardiovascular death', 'timeFrame': '12 months', 'description': 'Cardiovascular death'}, {'measure': 'Acute myocardial infarction of the lesion treated/functionally evaluated', 'timeFrame': '12 months', 'description': 'Acute myocardial infarction of the lesion treated/functionally evaluated'}, {'measure': 'Acute myocardial infarction from any lesion', 'timeFrame': '12 months', 'description': 'Acute myocardial infarction from any lesion'}, {'measure': 'Need for revascularization of the lesion treated/functionally evaluated', 'timeFrame': '12 months', 'description': 'Need for revascularization of the lesion treated/functionally evaluated'}, {'measure': 'Need for revascularization of any lesion', 'timeFrame': '12 months', 'description': 'Need for revascularization of any lesion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous Coronary Intervention (PCI)', 'Fractional Flow Reserve'], 'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165.'}, {'pmid': '26333474', 'type': 'BACKGROUND', 'citation': "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': '33258564', 'type': 'BACKGROUND', 'citation': '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': '34991824', 'type': 'BACKGROUND', 'citation': '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': '32565755', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.', 'detailedDescription': 'Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI), and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Facing intermediate coronary lesions the use of pressure wires is the standar of care, however, limitations in the management of angiographically intermediate coronary lesions continue to be a challenge for the interventional cardiologist. The measurement of fractional flow reserve (FFR) to determine the hemodynamic relevance of coronary stenosis has been shown to be a technique that improves the prognosis and cost-efficiency of the procedures when compared to visual angiographic interpretation alone. Due to this evidence, the use of FFR to guide interventional procedures is a class I recommendation in current clinical practice guidelines.\n\nPatients with multivessel coronary artery disease are another field in the use of pressure guiding. In these patients, the use of FFR has demonstrated the reclassification of the severity of coronary lesions in up to 40% of cases, modifying the number of functionally significant lesions and making it possible to reorient therapeutic decisions, avoiding interventional treatment of non-significant lesions and with a better prognosis.\n\nHowever, 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.) and time consuming. In addition, the presence of atrioventricular block, asthma or severe chronic obstructive pulmonary disease are 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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients \\>18 years old and,\n* 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,\n* Use of Navvus pressure microcatheter both for functional diagnosis and for post-PCI evaluation of the different vessels and,\n* Patients who have signed the Informed Consent.\n\nExclusion Criteria:\n\n* Patients with intolerance or contraindication to adenosine.\n* Hemodynamically unstable patients, acute phase of a STEACS.\n* Patient with significant comorbidity with limited life expectancy.\n* Patients with the patient's express refusal to participate in the study.\n* Pregnant or breastfeeding female patients."}, 'identificationModule': {'nctId': 'NCT06273293', 'briefTitle': 'Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients', 'orgStudyIdInfo': {'id': 'EPIC35-PROMETEUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Percutaneous coronary intervention (PCI) and guide wire post PCI in multivessel patients', 'interventionNames': ['Diagnostic Test: Fractional Flow Reserve']}], 'interventions': [{'name': 'Fractional Flow Reserve', 'type': 'DIAGNOSTIC_TEST', 'description': '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):\n\n1. 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.\n2. 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.\n3. Determination of the diastolic dPR index: the average value (2-3 determinations).\n4. 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.', 'armGroupLabels': ['Percutaneous coronary intervention (PCI) and guide wire post PCI in multivessel patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03550', 'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario San Juan de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '06080', 'city': 'Badajoz', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '21005', 'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'SANTIAGO J CAMACHO FREIRE, MD, PhD', 'role': 'CONTACT', 'email': 'hemodinamica.cardiologia.huelva@gmail.com', 'phone': '0034677981941'}, {'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '0034987876135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}