Coroflex® ISAR NEO PMCF Study (rEPIC07)

Fundación EPIC

Status

Enrolling

Conditions

Ischemic Heart Disease

Coronary Artery Disease (CAD)

Treatments

Device: Coroflex® ISAR NEO coronary stent system

Study type

Observational

Funder types

Other

Identifiers

NCT05698732

Coroflex® ISAR NEO PMCF Study

Details and patient eligibility

About

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Full description

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Coroflex® ISAR NEO is intended to be used for

Patients must be at least 18 years of age AND
The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
Patients with Novo lesion length 2-4 mm AND
Informed consent signed

Exclusion criteria

Patients with express refusal by the patient to participate in the study.
Patients pregnant women and lactating women.
Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
Patients with contraindications or hypersensitivity to sirolimus.
Patients with a life expectancy of less than 2 years.
Patients included in other clinical trials.