Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:16 PM
Study NCT ID:
NCT07399002
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LONG NAGOMI™ PMCF STUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1039}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '1 year', 'description': 'Target Lesion Failure defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure.'}], 'secondaryOutcomes': [{'measure': 'Device success', 'timeFrame': 'Periprocedural', 'description': 'Device success defined as delivery success (achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter) with a final residual diameter stenosis of the target lesion of \\< 20% by visual assessment and/or \\< 30% by QCA, using the assigned device only.'}, {'measure': 'Safety of the stent: Freedom from Accidental dislodgement of the stent', 'timeFrame': 'Periprocedural', 'description': 'Safety of the stent defined as an absence of Accidental stent dislodgement'}, {'measure': 'Safety of the stent: Freedom from Balloon rupture', 'timeFrame': 'Periprocedural', 'description': 'Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture.'}, {'measure': 'Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture', 'timeFrame': 'Periprocedural', 'description': 'Safety of the stent defined as an absence of o Hypotube rupture o Hypotube rupture.'}, {'measure': 'Safety of the procedure: Freedom from Challenging withdrawal', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure defined as an absence of Challenging withdrawal'}, {'measure': 'Safety of the procedure: Freedom from coronary perforation', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure defined as an absence of coronary perforation'}, {'measure': 'Safety of the procedure: Freedom from dissection >C', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure defined as an absence of dissection \\>C'}, {'measure': 'Safety of the procedure: Freedom from no-reflow', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure defined as an absence of no-reflow'}, {'measure': 'Safety of the procedure: Freedom from stent thrombosis', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure defined as an absence stent thrombosis'}, {'measure': 'Procedure success', 'timeFrame': 'Periprocedural', 'description': 'To assess the procedure success rate defined as the achievement of \\< 20% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave myocardial Infarction, or need for new revascularization of the target lesion during the hospital stay.'}, {'measure': 'Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions', 'timeFrame': 'Periprocedural', 'description': 'To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions'}, {'measure': 'Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels', 'timeFrame': 'Periprocedural', 'description': 'To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels'}, {'measure': 'Performance of the Ultimaster Nagomi™ stent in Distal vessels', 'timeFrame': 'Periprocedural', 'description': 'To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels'}, {'measure': 'Angina status assessment Seattle Angina Questionnaire (SAQ)', 'timeFrame': 'Baseline', 'description': 'Angina status assessment Seattle Angina Questionnaire (SAQ)'}, {'measure': 'Angina status assessment Seattle Angina Questionnaire (SAQ)', 'timeFrame': '12 monts', 'description': 'Angina status assessment Seattle Angina Questionnaire (SAQ)'}, {'measure': 'Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire', 'timeFrame': 'After PCI', 'description': 'Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire'}, {'measure': 'Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire', 'timeFrame': '12 Months', 'description': 'Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire'}, {'measure': 'Cardiovascular death', 'timeFrame': '12 months', 'description': 'Percentage of cardiovascular death'}, {'measure': 'Target-vessel related myocardial infarction', 'timeFrame': '12 Months', 'description': 'Percentage of target-vessel related myocardial infarction'}, {'measure': 'Clinically driven target lesion revascularization', 'timeFrame': '12 months', 'description': 'Percentage of clinically driven target lesion revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR (Medical Device Regulations)', 'PMCF (Post-Market Clinical Follow-up)'], 'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Khan, M. (2024). Prevalence of in-stent restenosis in patients having drug eluting stents with lengths exceeding 40mm: a single-center study. JHRR, 4(2), 837-841. doi.org/10.61919/jhrr.v4i2.960'}, {'pmid': '38832189', 'type': 'BACKGROUND', 'citation': 'Khanal S, Agarwal A, Kumar B. One-Year Outcomes of Long Coronary Drug-Eluting Stents (>/=40 MM) in Patients With Diffuse Coronary Artery Disease: Findings From a Tertiary Care Hospital in North India. Cureus. 2024 May 3;16(5):e59611. doi: 10.7759/cureus.59611. eCollection 2024 May.'}, {'pmid': '39131646', 'type': 'BACKGROUND', 'citation': 'Park KE, Wu CJ, Chehab B, Maksoud A, Bertolet B, Ying SW, Simoes T, Pingle SC, Chang CJ. One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial. J Soc Cardiovasc Angiogr Interv. 2023 May 18;2(4):101001. doi: 10.1016/j.jscai.2023.101001. eCollection 2023 Jul-Aug.'}, {'pmid': '28017259', 'type': 'BACKGROUND', 'citation': 'Patra S, Chakraborty RN, Pande A, Banerjee S, Jena M, Mandal PC, De SK, Khan A, Das SS, Ghosh D, Nag R. Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30mm) de novo coronary artery stenosis. Cardiovasc Revasc Med. 2017 Apr-May;18(3):160-164. doi: 10.1016/j.carrev.2016.12.007. Epub 2016 Dec 15.'}, {'pmid': '35621281', 'type': 'BACKGROUND', 'citation': 'Gautier A, Hovasse T, Arroyo D, Unterseeh T, Garot P, Champagne S, Neylon A, Sanguineti F, Benamer H, Chevalier B, Lefevre T. Safety and efficacy of 48 mm Xience Xpedition everolimus-eluting stent for the treatment of long coronary lesions. Catheter Cardiovasc Interv. 2022 Aug;100(2):179-187. doi: 10.1002/ccd.30249. Epub 2022 May 27.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ \\_stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.', 'detailedDescription': 'The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing PCI with implantation of a Long Nagomi stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet ALL inclusion criteria will be included:\n* Patients aged ≥ 18 years AND;\n* Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND;\n* Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND;\n* Patients who have been informed of the characteristics of the study and have provided written informed consent AND;\n* Intention to treat all lesions with the Ultimaster Nagomi™ stent\n\nExclusion Criteria:\n\n* Patients must not meet any of the following exclusion criteria:\n* Patients who expressly decline to participate in the study.\n* Pregnant or breastfeeding women.\n* Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).\n* Patients with contraindications or hypersensitivity to sirolimus.\n* Patients with a life expectancy of less than 2 years.\n* Patients in whom any surgery requiring general anesthesia is planned, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines.\n* Patients included in other clinical trials that did not reach the primary objective.'}, 'identificationModule': {'nctId': 'NCT07399002', 'acronym': 'LONG NAGOMI', 'briefTitle': 'LONG NAGOMI™ PMCF STUDY', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Long Coronary Lesions: Safety and Performance of the Ultimaster Nagomi™ Stent in This Setting With a One-to-one Approach -One Lesion, One Stent- LONG NAGOMI™ PMCF STUDY', 'orgStudyIdInfo': {'id': 'rEPIC19- LONG NAGOMI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: LONG NAGOMI']}], 'interventions': [{'name': 'LONG NAGOMI', 'type': 'DEVICE', 'description': 'Patients in whom treatment with long nagomi has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '24008', 'city': 'León', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Leon', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '39008', 'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'centralContacts': [{'name': 'TAMARA GARCIA CAMARERO, MD, PhD', 'role': 'CONTACT', 'email': 'tgcamarero@gmail.com', 'phone': '0034615420460'}, {'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '00987876135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}