AzTrials
AzTrials

Coronary Artery DiseaseLONG NAGOMINCT07399002

LONG NAGOMI™ PMCF STUDY

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 10 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LONG NAGOMI
Type of treatment
Medical device
How many people
1,039 participants
Where
10 sitesSpain
Study dates
27 Feb 2026to 1 Jan 2029
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing PCI with implantation of a Long Nagomi stent

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

TAMARA GARCIA CAMARERO, MD, PhD contact

0034615420460

tgcamarero@gmail.com

FUNDACION EPIC contact

00987876135

iepic@fundacionepic.org

10 sites in 1 country

Spain10 sites, 10 recruiting

  • Hospital Universitario de Cabueñes

    Cabueñes, 33394

    Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005

    Recruiting

  • Hospital General Universitario de Elche

    Elche, 03203

    Recruiting

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005

    Recruiting

  • Hospital Universitario de Leon

    León, 24008

    Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga, 29010

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

About this 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

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.

Read the 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.

Being tested
LONG NAGOMI
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up)
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LONG NAGOMIDevice

    Patients in whom treatment with long nagomi has been attempted

Study groups in NCT07399002
Study groupRoleWhat they receive
Coronary Artery Disease (CAD)Not described
Receives: Device: LONG NAGOMI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (20)

  1. 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.

    Measured: Periprocedural

  2. Safety of the stent: Freedom from Accidental dislodgement of the stent

    Safety of the stent defined as an absence of Accidental stent dislodgement

    Measured: Periprocedural

  3. Safety of the stent: Freedom from Balloon rupture

    Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture.

    Measured: Periprocedural

  4. 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.

    Measured: Periprocedural

  5. Safety of the procedure: Freedom from Challenging withdrawal

    Safety of the procedure defined as an absence of Challenging withdrawal

    Measured: Periprocedural

  6. Safety of the procedure: Freedom from coronary perforation

    Safety of the procedure defined as an absence of coronary perforation

    Measured: Periprocedural

  7. Safety of the procedure: Freedom from dissection >C

    Safety of the procedure defined as an absence of dissection >C

    Measured: Periprocedural

  8. Safety of the procedure: Freedom from no-reflow

    Safety of the procedure defined as an absence of no-reflow

    Measured: Periprocedural

  9. Safety of the procedure: Freedom from stent thrombosis

    Safety of the procedure defined as an absence stent thrombosis

    Measured: Periprocedural

  10. 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.

    Measured: Periprocedural

  11. Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions

    To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions

    Measured: Periprocedural

  12. Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels

    To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels

    Measured: Periprocedural

  13. Performance of the Ultimaster Nagomi™ stent in Distal vessels

    To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels

    Measured: Periprocedural

  14. Angina status assessment Seattle Angina Questionnaire (SAQ)

    Angina status assessment Seattle Angina Questionnaire (SAQ)

    Measured: Baseline

  15. Angina status assessment Seattle Angina Questionnaire (SAQ)

    Angina status assessment Seattle Angina Questionnaire (SAQ)

    Measured: 12 monts

  16. Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire

    Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire

    Measured: After PCI

  17. Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire

    Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire

    Measured: 12 Months

  18. Cardiovascular death

    Percentage of cardiovascular death

    Measured: 12 months

  19. Target-vessel related myocardial infarction

    Percentage of target-vessel related myocardial infarction

    Measured: 12 Months

  20. Clinically driven target lesion revascularization

    Percentage of clinically driven target lesion revascularization

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start27 Feb 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,039 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399002
Sponsor's protocol ID
rEPIC19- LONG NAGOMI
Acronym
LONG NAGOMI
Status last verified
Sep 2026
First submitted
24 Nov 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35621281

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TAMARA GARCIA CAMARERO, MD, PhD (0034615420460, tgcamarero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07399002, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in