LONG NAGOMI™ PMCF STUDY

Official title

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

Overview

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.

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.

Interventions

• Device LONG NAGOMI
  Patients in whom treatment with long nagomi has been attempted

Primary outcome measures

• Target Lesion Failure (TLF) [Time frame: 1 year]

Secondary outcome measures (12)

• Device success [Time frame: Periprocedural]
• Safety of the stent: Freedom from Accidental dislodgement of the stent [Time frame: Periprocedural]
• Safety of the stent: Freedom from Balloon rupture [Time frame: Periprocedural]
• Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture [Time frame: Periprocedural]
• Safety of the procedure: Freedom from Challenging withdrawal [Time frame: Periprocedural]
• Safety of the procedure: Freedom from coronary perforation [Time frame: Periprocedural]
• Safety of the procedure: Freedom from dissection >C [Time frame: Periprocedural]
• Safety of the procedure: Freedom from no-reflow [Time frame: Periprocedural]
• Safety of the procedure: Freedom from stent thrombosis [Time frame: Periprocedural]
• Procedure success [Time frame: Periprocedural]
• Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions [Time frame: Periprocedural]
• Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels [Time frame: Periprocedural]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Spain · 7 centers

• Hospital Universitario de Cabueñes — Cabueñes
• Hospital General Universitario de Elche — Elche
• Hospital Universitario Juan Ramón Jiménez — Huelva
• Hospital Universitario de Leon — León
• Hospital Universitario Regional de Málaga — Málaga
• Hospital Universitario de Navarra — Pamplona
• Hospital Universitario Marqués de Valdecilla — Santander

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. PMID 38832189
• 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
• 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
• 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

Identifiers

NCT: NCT07399002 · rEPIC19- LONG NAGOMI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗