LONG NAGOMI™ PMCF STUDY

Fundación EPIC1,039 enrolled

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.

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

OBSERVATIONAL

Enrollment

1,039

Conditions

Coronary Artery Disease Ischemic Heart Disease

Interventions

LONG NAGOMIDEVICE

Patients in whom treatment with long nagomi has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Hospital Universitario de Cabueñes

Cabueñes, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

TAMARA GARCIA CAMARERO, MD, PhD

CONTACT

0034615420460 tgcamarero@gmail.com

FUNDACION EPIC

CONTACT

00987876135 iepic@fundacionepic.org

Data from ClinicalTrials.gov

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