An observational study in Coronary Artery Disease and Ischemic Heart Disease, sponsored by Fundación EPIC. Recruiting at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Fundación EPIC · Observational
Among 33 studies in Coronary Artery Disease by Fundación EPIC — 13 open to participants now, 20 under way, none of them phase 3. Coronary Artery Disease · Fundación EPIC.
Among the 33 studies in Coronary Artery Disease by Fundación EPIC, this one is the 3rd largest by planned enrollment of the 20 observational ones that give a count, is the only one that started in 2026, is one of 20 observational ones, reaches primary completion later than 15 of the 19 other live ones, and was the 32nd registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →13 of the 33 studies in Coronary Artery Disease by Fundación EPIC are open now, in 7 countries. Recruiting first, the newest first:
Fundación EPIC · Sites in United States, Belgium, Spain and 1 more country
Fundación EPIC · Sites in Spain
Fundación EPIC · Sites in Spain
Fundación EPIC · Sites in Hong Kong
Fundación EPIC · Sites in Spain
By country, each count listing its studies:
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 1,039 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Median enrollment 200 across the 13 interventional studies, 375 across the 20 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
10 of the studies in Coronary Artery Disease by Fundación EPIC that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06448637Fundación EPICDRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) | 2026-12-01 |
| NCT05788432Fundación EPICSequent Extended Study | 2026-12-01 |
| NCT05617599Fundación EPICSUPRAFLEX CRUZ PMCF Study ( rEpic05 ) | 2026-12-01 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07260474Fundación EPICComparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure | 2026-12-31 |
Among the 33 studies in Coronary Artery Disease by Fundación EPIC, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Patients undergoing PCI with implantation of a Long Nagomi stent
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: LONG NAGOMI
Patients in whom treatment with long nagomi has been attempted
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.
Time frame: 1 year
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.
Time frame: Periprocedural
Safety of the stent: Freedom from Accidental dislodgement of the stent
Safety of the stent defined as an absence of Accidental stent dislodgement
Time frame: Periprocedural
Safety of the stent: Freedom from Balloon rupture
Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture.
Time frame: 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.
Time frame: Periprocedural
Safety of the procedure: Freedom from Challenging withdrawal
Safety of the procedure defined as an absence of Challenging withdrawal
Time frame: Periprocedural
Safety of the procedure: Freedom from coronary perforation
Safety of the procedure defined as an absence of coronary perforation
Time frame: Periprocedural
Safety of the procedure: Freedom from dissection >C
Safety of the procedure defined as an absence of dissection \>C
Time frame: Periprocedural
Safety of the procedure: Freedom from no-reflow
Safety of the procedure defined as an absence of no-reflow
Time frame: Periprocedural
Safety of the procedure: Freedom from stent thrombosis
Safety of the procedure defined as an absence stent thrombosis
Time frame: 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.
Time frame: Periprocedural
Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions
To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions
Time frame: Periprocedural
Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels
To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels
Time frame: Periprocedural
Performance of the Ultimaster Nagomi™ stent in Distal vessels
To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels
Time frame: Periprocedural
Angina status assessment Seattle Angina Questionnaire (SAQ)
Angina status assessment Seattle Angina Questionnaire (SAQ)
Time frame: Baseline
Angina status assessment Seattle Angina Questionnaire (SAQ)
Angina status assessment Seattle Angina Questionnaire (SAQ)
Time frame: 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
Time frame: 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
Time frame: 12 Months
Cardiovascular death
Percentage of cardiovascular death
Time frame: 12 months
Target-vessel related myocardial infarction
Percentage of target-vessel related myocardial infarction
Time frame: 12 Months
Clinically driven target lesion revascularization
Percentage of clinically driven target lesion revascularization
Time frame: 12 months
Started Feb 2026 (actual). Primary completion is estimated for Jan 2028, 22 months after the start.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 22 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Fundación EPIC