LONG NAGOMI™ PMCF STUDY

NCT07399002 | Recruiting DMC

• 1 other identifier: rEPIC19- LONG NAGOMI
• Study Type: observational
• Target: 1,039
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Device success

  Periprocedural

• Safety of the stent: Freedom from Accidental dislodgement of the stent

  Periprocedural

• Safety of the stent: Freedom from Balloon rupture

  Periprocedural

• Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture

  Periprocedural

• Safety of the procedure: Freedom from Challenging withdrawal

  Periprocedural

Study Arms (1)

Coronary Artery Disease (CAD)

Device: LONG NAGOMI

Interventions

LONG NAGOMI DEVICE

Patients in whom treatment with long nagomi has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

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

Study Population

Patients undergoing PCI with implantation of a Long Nagomi stent

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (6)

Hospital Universitario de Cabueñes

Cabueñes, 33394, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, 03203, Spain

RECRUITING

Hospital Universitario de Leon

León, 24008, Spain

RECRUITING

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

RECRUITING

Related Publications (5)

• 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

  BACKGROUND

• 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: 38832189 BACKGROUND

• 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: 39131646 BACKGROUND

• 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: 28017259 BACKGROUND

• 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.

  PMID: 35621281 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

TAMARA GARCIA CAMARERO, MD, PhD

CONTACT

0034615420460; tgcamarero@gmail.com

FUNDACION EPIC

CONTACT

00987876135; iepic@fundacionepic.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 10, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (6)