LONG NAGOMI™ PMCF STUDY (LONG NAGOMI)

September 10, 2026 updated by: Fundación EPIC

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1039

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Cabueñes, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
      • Elche, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramón Jiménez
      • León, Spain, 24008
        • Recruiting
        • Hospital Universitario de Leon
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Regional de Málaga
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: Periprocedural
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
Time Frame: Periprocedural
Safety of the stent defined as an absence of Accidental stent dislodgement
Periprocedural
Safety of the stent: Freedom from Balloon rupture
Time Frame: Periprocedural
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
Time Frame: Periprocedural
Safety of the stent defined as an absence of o Hypotube rupture o Hypotube rupture.
Periprocedural
Safety of the procedure: Freedom from Challenging withdrawal
Time Frame: Periprocedural
Safety of the procedure defined as an absence of Challenging withdrawal
Periprocedural
Safety of the procedure: Freedom from coronary perforation
Time Frame: Periprocedural
Safety of the procedure defined as an absence of coronary perforation
Periprocedural
Safety of the procedure: Freedom from dissection >C
Time Frame: Periprocedural
Safety of the procedure defined as an absence of dissection >C
Periprocedural
Safety of the procedure: Freedom from no-reflow
Time Frame: Periprocedural
Safety of the procedure defined as an absence of no-reflow
Periprocedural
Safety of the procedure: Freedom from stent thrombosis
Time Frame: Periprocedural
Safety of the procedure defined as an absence stent thrombosis
Periprocedural
Procedure success
Time Frame: Periprocedural
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
Time Frame: Periprocedural
To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions
Periprocedural
Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels
Time Frame: Periprocedural
To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels
Periprocedural
Performance of the Ultimaster Nagomi™ stent in Distal vessels
Time Frame: Periprocedural
To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels
Periprocedural
Angina status assessment Seattle Angina Questionnaire (SAQ)
Time Frame: Baseline
Angina status assessment Seattle Angina Questionnaire (SAQ)
Baseline
Angina status assessment Seattle Angina Questionnaire (SAQ)
Time Frame: 12 monts
Angina status assessment Seattle Angina Questionnaire (SAQ)
12 monts
Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire
Time Frame: After PCI
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
Time Frame: 12 Months
Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire
12 Months
Cardiovascular death
Time Frame: 12 months
Percentage of cardiovascular death
12 months
Target-vessel related myocardial infarction
Time Frame: 12 Months
Percentage of target-vessel related myocardial infarction
12 Months
Clinically driven target lesion revascularization
Time Frame: 12 months
Percentage of clinically driven target lesion revascularization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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