LONG NAGOMI™ PMCF STUDY (LONG NAGOMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: LONG NAGOMI

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1039

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 00987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: TAMARA GARCIA CAMARERO, MD, PhD; Phone Number: 0034615420460; Email: tgcamarero@gmail.com

Study Locations

• Spain
  • Cabueñes, Spain, 33394
    • Recruiting
    • Hospital Universitario de Cabueñes
  • Elche, Spain, 03203
    • Recruiting
    • Hospital General Universitario de Elche
  • León, Spain, 24008
    • Recruiting
    • Hospital Universitario de Leon
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Regional de Malaga
  • Pamplona, Spain, 31008
    • Recruiting
    • Hospital Universitario de Navarra
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI with implantation of a Long Nagomi stent

Description

Inclusion Criteria:

• Patients who meet ALL inclusion criteria will be included:
• Patients aged ≥ 18 years AND;
• 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;
• Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND;
• Patients who have been informed of the characteristics of the study and have provided written informed consent AND;
• Intention to treat all lesions with the Ultimaster Nagomi™ stent

Exclusion Criteria:

• Patients must not meet any of the following exclusion criteria:
• Patients who expressly decline to participate in the study.
• Pregnant or breastfeeding women.
• Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).
• Patients with contraindications or hypersensitivity to sirolimus.
• Patients with a life expectancy of less than 2 years.
• 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.
• Patients included in other clinical trials that did not reach the primary objective.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Device: LONG NAGOMI; Patients in whom treatment with long nagomi has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	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.	Periprocedural
Safety of the stent: Freedom from Accidental dislodgement of the stent	Safety of the stent defined as an absence of Accidental stent dislodgement	Periprocedural
Safety of the stent: Freedom from Balloon rupture	Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture.	Periprocedural
Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture	Safety of the stent defined as an absence of o Hypotube rupture o Hypotube rupture.	Periprocedural
Safety of the procedure: Freedom from Challenging withdrawal	Safety of the procedure defined as an absence of Challenging withdrawal	Periprocedural
Safety of the procedure: Freedom from coronary perforation	Safety of the procedure defined as an absence of coronary perforation	Periprocedural
Safety of the procedure: Freedom from dissection >C	Safety of the procedure defined as an absence of dissection >C	Periprocedural
Safety of the procedure: Freedom from no-reflow	Safety of the procedure defined as an absence of no-reflow	Periprocedural
Safety of the procedure: Freedom from stent thrombosis	Safety of the procedure defined as an absence stent thrombosis	Periprocedural
Procedure success	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.	Periprocedural
Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions	To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions	Periprocedural
Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels	To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels	Periprocedural
Performance of the Ultimaster Nagomi™ stent in Distal vessels	To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels	Periprocedural
Angina status assessment Seattle Angina Questionnaire (SAQ)	Angina status assessment Seattle Angina Questionnaire (SAQ)	Baseline
Angina status assessment Seattle Angina Questionnaire (SAQ)	Angina status assessment Seattle Angina Questionnaire (SAQ)	12 monts
Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire	Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire	After PCI
Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire	Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire	12 Months
Cardiovascular death	Percentage of cardiovascular death	12 months
Target-vessel related myocardial infarction	Percentage of target-vessel related myocardial infarction	12 Months
Clinically driven target lesion revascularization	Percentage of clinically driven target lesion revascularization	12 months

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: rEPIC19- LONG NAGOMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No