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Coroflex® ISAR NEO PMCF Study

RecruitingN/A

Sponsor: Fundación EPIC

Conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease

Interventions: Coroflex® ISAR NEO coronary stent system

Countries: France, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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 in whom anti-platelet and/or anti-coagulation therapy is contraindicated
* Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
* Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
* Patients with known sensitivity to contrast agents who cannot be premedicated.
* Patients with contraindications or hypersensitivity to sirolimus
* Patients with a life expectancy of less than 2 years
* Patients included in other clinical trials

Locations (23)

Aix-en-Provence, France
Ajaccio, France
Bordeaux, France
Caen, France
Colmar, France
Lille, France
Paris, France
Saint-Laurent-du-Var, France
A Coruña, Spain
Badajoz, Spain
Badalona, Spain
Barakaldo, Spain
Barcelona, Spain
Barcelona, Spain
Cáceres, Spain
Ciudad Real, Spain
Huelva, Spain
León, Spain
Lugo, Spain
Málaga, Spain
Málaga, Spain
Zaragoza, Spain
Wigan, United Kingdom