Health Trials

LONG NAGOMI™ PMCF STUDY

ConditionsCoronary Artery DiseaseIschemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

Patients undergoing PCI with implantation of a Long Nagomi stent

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • LONG NAGOMI

    Device

    Patients in whom treatment with long nagomi has been attempted

Treatment groups

1,039 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease (CAD)1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

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.

Time frame
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

Time frame
Periprocedural
3

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
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.

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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